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Dose Finding Study of Gadavist in Central Nervous System (CNS) Magnetic Resonance Imaging (MRI)

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ClinicalTrials.gov Identifier: NCT00862459
Recruitment Status : Completed
First Posted : March 17, 2009
Results First Posted : January 30, 2012
Last Update Posted : January 13, 2014
Sponsor:
Information provided by (Responsible Party):
Bayer

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Diagnostic
Conditions Brain Diseases
Spinal Cord Diseases
Interventions Drug: Gadobutrol~0.03 mmol/kg BW (Gadavist, Gadovist, BAY86-4875)
Drug: Gadobutrol~0.1 mmol/kg BW (Gadavist, Gadovist, BAY86-4875)
Drug: Gadobutrol~0.3 mmol/kg BW (Gadavist, Gadovist, BAY86-4875)
Drug: OptiMARK~0.1 mmol/kg BW
Enrollment 237
Recruitment Details The date of the first participant's first visit was 27 August 2005. The date of the last participant's last visit was 26 March 2007.
Pre-assignment Details 242 participants were screened: 5 were screening failures (withdrew consent, did not meet study criteria, other). The remaining 237 were randomized to the 0.3, 0.1, or 0.03 millimole per kilogram (mmol/kg) group.
Arm/Group Title Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875) Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875) Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875)
Hide Arm/Group Description Participant received one dose of 0.03 mmol/kg body weight (BW) of Gadobutrol and one dose of 0.1 mmol/kg BW of OptiMARK. The order in which the participants received Gadobutrol and OptiMARK was randomized. Gadobutrol was administered via a power injector at a rate of 5 milliliter per second (mL/s) followed by a 20 mL 0.9% saline flush at the same rate. Participant received one dose of 0.1 mmol/kg BW of Gadobutrol and one dose of 0.1 mmol/kg BW of OptiMARK. The order in which the participants received Gadobutrol and OptiMARK was randomized. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate. Participant received one dose of 0.3 mmol/kg BW of Gadobutrol and one dose of 0.1 mmol/kg BW of OptiMARK. The order in which the participants received Gadobutrol and OptiMARK was randomized. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
Period Title: Overall Study
Started 72 93 72
Participants Received Treatment 70 [1] 90 [2] 69 [3]
Completed 66 85 66
Not Completed 6 8 6
Reason Not Completed
Lost to Follow-up             1             2             2
Protocol Violation             1             0             0
Withdrawal by Subject             1             1             3
Adverse Event             0             1             0
Personal reasons             1             0             0
Operation             1             1             0
Intravenous (IV) site problems             1             0             1
Unable to hold still for imaging             0             1             0
Inclusion/exclusion criteria not met             0             1             0
Administrative problems             0             1             0
[1]
Number reflects all treated participants of whom 67 received Gadobutrol and 70 received OptiMARK
[2]
Number reflects all treated participants of whom 90 received Gadobutrol and 88 received OptiMARK
[3]
Number reflects all treated participants of whom 68 received Gadobutrol and 69 received OptiMARK
Arm/Group Title Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875) Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875) Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875) Total
Hide Arm/Group Description Participant received one dose of 0.03 millimole per kilogram of body weight (mmol/kg BW) of Gadobutrol and one dose of 0.1 mmol/kg BW of OptiMARK. The order in which the participants received Gadobutrol and OptiMARK was randomized. Gadobutrol was administered via a power injector at a rate of 5 milliliter per second (mL/s) followed by a 20 mL 0.9% saline flush at the same rate. Participant received one dose of 0.1 mmol/kg BW of Gadobutrol and one dose of 0.1 mmol/kg BW of OptiMARK. The order in which the participants received Gadobutrol and OptiMARK was randomized. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate. Participant received one dose of 0.3 mmol/kg BW of Gadobutrol and one dose of 0.1 mmol/kg BW of OptiMARK. The order in which the participants received Gadobutrol and OptiMARK was randomized. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate. Total of all reporting groups
Overall Number of Baseline Participants 70 90 69 229
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Measure Type: Number
Unit of measure:  Years
Number Analyzed 70 participants 90 participants 69 participants 229 participants
<45 years 36 42 29 107
45-64 years 24 39 28 91
>=65 years 10 9 12 31
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 70 participants 90 participants 69 participants 229 participants
Female
33
  47.1%
58
  64.4%
38
  55.1%
129
  56.3%
Male
37
  52.9%
32
  35.6%
31
  44.9%
100
  43.7%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 70 participants 90 participants 69 participants 229 participants
Caucasian 30 45 29 104
Black 7 8 3 18
Hispanic 3 6 3 12
Asian 1 1 0 2
Other 29 30 34 93
1.Primary Outcome
Title Categorical Visualization Score (CVS)
Hide Description The primary visualization variables (number [no.] of lesions detected, border delineation, contrast enhancement, internal morphology) were condensed to a composite score (CVS). Each variable was considered a category; the CVS was calculated as: CVS=(No. of categories with increase over precontrast)-(No. of categories with decrease over precontrast). The possible outcomes of the CVS for a participant and each reader were in the range of - 3 to +4. The CVS was averaged across the 3 blinded readers, producing 1 mean CVS per participant. The higher the CVS, the more effective the treatment.
Time Frame up to 2 hours after the injection of study medication
Hide Outcome Measure Data
Hide Analysis Population Description
The per protocol set (PPS), which included all participants with valid images who received +/-10% of the intended dose of study drug and had no major protocol or Magnetic Resonance Imaging (MRI) procedure deviations (excluding one participant with insufficient images)
Arm/Group Title Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875) Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875) Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875)
Hide Arm/Group Description:
Participant received one dose of 0.03 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
Participant received one dose of 0.1 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
Participant received one dose of 0.3 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
Overall Number of Participants Analyzed 61 55 56
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
1.43  (1.07) 2.02  (1.04) 1.98  (1.20)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875), Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875)
Comments 2 sample t-test between the dose groups
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.003
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.59
Parameter Dispersion
Type: Standard Deviation
Value: 1.49
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875), Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.844
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.04
Parameter Dispersion
Type: Standard Deviation
Value: 1.59
Estimation Comments [Not Specified]
2.Primary Outcome
Title Difference in Number of Lesions Detected in Pre-contrast and Combined Pre-/Post-contrast MRI.
Hide Description Three blinded readers evaluated the unenhanced MRI sets and the combined unenhanced/gadobutrol-enhanced MRI sets to evaluate the number of lesions, which was then averaged to produce an average reader value.
Time Frame up to 2 hours after the injection of study medication
Hide Outcome Measure Data
Hide Analysis Population Description
PPS (excluding one participant with insufficient images)
Arm/Group Title Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875) Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875) Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875)
Hide Arm/Group Description:
Participant received one dose of 0.03 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
Participant received one dose of 0.1 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
Participant received one dose of 0.3 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
Overall Number of Participants Analyzed 61 55 56
Mean (Standard Deviation)
Unit of Measure: Lesions per participant
-0.03  (1.82) 0.04  (2.28) 0.09  (2.22)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875), Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method confidence interval using t-distribution
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.069
Confidence Interval 95%
-0.825 to 0.69
Parameter Dispersion
Type: Standard Deviation
Value: 2.92
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875), Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method confidence interval using t-distribution
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.53
Confidence Interval 95%
-0.90 to 0.79
Parameter Dispersion
Type: Standard Deviation
Value: 3.18
Estimation Comments [Not Specified]
3.Primary Outcome
Title Assessment of Lesion Contrast Enhancement
Hide Description The blinded readers assessed the degree of contrast enhancement for each lesion on a 4-point scale where 1 = no enhancement and 4 = excellent enhancement, which was then averaged to produce an average reader score.
Time Frame up to 2 hours after the injection of study medication
Hide Outcome Measure Data
Hide Analysis Population Description
PPS (excluding subjects with no lesion detected)
Arm/Group Title Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875) Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875) Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875)
Hide Arm/Group Description:
Participant received one dose of 0.03 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
Participant received one dose of 0.1 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
Participant received one dose of 0.3 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
Overall Number of Participants Analyzed 58 55 53
Mean (Standard Deviation)
Unit of Measure: scores on a scale
0.98  (0.93) 1.78  (1.07) 1.79  (1.15)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875), Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method confidence interval using t-distribution
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.80
Confidence Interval 95%
-1.17 to -0.42
Parameter Dispersion
Type: Standard Deviation
Value: 1.42
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875), Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method confidence interval using t-distribution
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.01
Confidence Interval 95%
-0.44 to 0.41
Parameter Dispersion
Type: Standard Deviation
Value: 1.57
Estimation Comments [Not Specified]
4.Primary Outcome
Title Assessment of Border Delineation
Hide Description The blinded readers assessed the delineation for each lesion on a 4-point scale where 1 = none and 4 = excellent, which was then averaged to produce an average reader score.
Time Frame up to 2 hours after the injection of study medication
Hide Outcome Measure Data
Hide Analysis Population Description
PPS (excluding subjects with no lesion detected)
Arm/Group Title Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875) Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875) Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875)
Hide Arm/Group Description:
Participant received one dose of 0.03 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
Participant received one dose of 0.1 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
Participant received one dose of 0.3 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
Overall Number of Participants Analyzed 58 55 53
Mean (Standard Deviation)
Unit of Measure: scores on a scale
0.28  (0.60) 0.68  (0.61) 0.70  (0.60)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875), Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method confidence interval using t-distribution
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.40
Confidence Interval 95%
-0.619 to -0.17
Parameter Dispersion
Type: Standard Deviation
Value: 0.86
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875), Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method confidence interval using t-distribution
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.02
Confidence Interval 95%
-0.25 to 0.22
Parameter Dispersion
Type: Standard Deviation
Value: 1.01
Estimation Comments [Not Specified]
5.Primary Outcome
Title Assessment of Internal Morphology
Hide Description The blinded readers assessed the degree of information available about internal morphology and structure for each lesion on a 3-point scale where 1 = poor and 3 = good, which was then averaged to produce an average reader score.
Time Frame up to 2 hours after the injection of study medication
Hide Outcome Measure Data
Hide Analysis Population Description
PPS (excluding subjects with no lesion detected)
Arm/Group Title Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875) Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875) Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875)
Hide Arm/Group Description:
Participant received one dose of 0.03 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
Participant received one dose of 0.1 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
Participant received one dose of 0.3 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
Overall Number of Participants Analyzed 58 55 53
Mean (Standard Deviation)
Unit of Measure: scores on a scale
0.52  (0.50) 0.90  (0.57) 0.80  (0.51)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875), Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method confidence interval using t-distribution
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.38
Confidence Interval 95%
-0.58 to -0.18
Parameter Dispersion
Type: Standard Deviation
Value: 0.76
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875), Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method confidence interval using t-distribution
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.10
Confidence Interval 95%
-0.10 to 0.31
Parameter Dispersion
Type: Standard Deviation
Value: 0.76
Estimation Comments [Not Specified]
6.Primary Outcome
Title Contrast to Noise Ratio (CNR) Between White and Gray Matter With Gadobutrol Perfusion MRI
Hide Description CNR between white and gray matter in the perfusion imaging was defined as the signal intensity (SI) difference between white and gray matter divided by the standard deviation of the SI of white matter. An independent radiologist evaluated the gadobutrol-enhanced perfusion MRI for signal intensity.
Time Frame up to 2 hours after the injection of study medication
Hide Outcome Measure Data
Hide Analysis Population Description
PPS (excluding participants with insufficient images)
Arm/Group Title Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875) Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875) Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875)
Hide Arm/Group Description:
Participant received one dose of 0.03 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
Participant received one dose of 0.1 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
Participant received one dose of 0.3 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
Overall Number of Participants Analyzed 60 56 55
Mean (Standard Deviation)
Unit of Measure: CNR
9.42  (11.4) 27.0  (75.6) 22.2  (15.2)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875), Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875)
Comments difference in CNR between doses and confidence interval
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method confidence interval using t-distribution
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -17.54
Confidence Interval 95%
-37.11 to 2.02
Parameter Dispersion
Type: Standard Deviation
Value: 76.45
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875), Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method confidence interval using t-distribution
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 4.74
Confidence Interval 95%
-15.86 to 25.35
Parameter Dispersion
Type: Standard Deviation
Value: 77.11
Estimation Comments [Not Specified]
7.Secondary Outcome
Title Accuracy Comparison of Gadobutrol Doses - Detection of Matched Lesions: Blinded Reader 1
Hide Description The percent accuracy (total number of lesions matching the comparator divided by the total number of lesions identified by gadobutrol) comparison of the 0.03 and 0.1 mmol/kg gadobutrol doses and the 0.1 and 0.3 mmol/kg gadobutrol doses using detection of all comparator-detected matched lesions was performed for blinded reader (BR) 1.
Time Frame up to 2 hours after the injection of study medication
Hide Outcome Measure Data
Hide Analysis Population Description
PPS (excluding subjects with no lesion detected)
Arm/Group Title Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875) Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875) Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875)
Hide Arm/Group Description:
Participant received one dose of 0.03 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
Participant received one dose of 0.1 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
Participant received one dose of 0.3 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
Overall Number of Participants Analyzed 60 56 55
Measure Type: Number
Unit of Measure: percentage of lesions
63.58 65.24 54.49
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875), Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.80
Comments [Not Specified]
Method Chi-squared
Comments Adjusted for clustering
Method of Estimation Estimation Parameter accuracy difference
Estimated Value 1.66
Confidence Interval 95%
-10.93 to 14.24
Parameter Dispersion
Type: Standard Error of the mean
Value: 6.29
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875), Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.13
Comments [Not Specified]
Method Chi-squared
Comments adjusted for clustering
Method of Estimation Estimation Parameter difference in accuracies
Estimated Value -10.75
Confidence Interval 95%
-24.41 to 2.90
Parameter Dispersion
Type: Standard Error of the mean
Value: 6.83
Estimation Comments [Not Specified]
8.Secondary Outcome
Title Accuracy Comparison of Gadobutrol Doses - Detection of Matched Lesions: Blinded Reader 2
Hide Description The percent accuracy (total number of lesions matching the comparator divided by the total number of lesions identified by gadobutrol) comparison of the 0.03 and 0.1 mmol/kg gadobutrol doses and the 0.1 and 0.3 mmol/kg gadobutrol doses using detection of all comparator-detected matched lesions was performed for BR 2
Time Frame up to 2 hours after the injection of study medication
Hide Outcome Measure Data
Hide Analysis Population Description
PPS (excluding subjects with no lesion detected)
Arm/Group Title Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875) Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875) Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875)
Hide Arm/Group Description:
Participant received one dose of 0.03 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
Participant received one dose of 0.1 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
Participant received one dose of 0.3 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
Overall Number of Participants Analyzed 59 56 54
Measure Type: Number
Unit of Measure: percentage of lesions
57.62 71.05 57.47
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875), Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.03
Comments [Not Specified]
Method Chi-squared
Comments adjusted for clustering
Method of Estimation Estimation Parameter difference in accuracy
Estimated Value 13.43
Confidence Interval 95%
1.53 to 25.33
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875), Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.02
Comments [Not Specified]
Method Chi-squared
Comments adjusted for clustering
Method of Estimation Estimation Parameter difference in accuracies
Estimated Value -13.58
Confidence Interval 95%
-25.07 to -2.09
Estimation Comments [Not Specified]
9.Secondary Outcome
Title Accuracy Comparison of Gadobutrol Doses - Detection of Matched Lesions: Blinded Reader 3
Hide Description The percent accuracy (total number of lesions matching the comparator divided by the total number of lesions identified by gadobutrol) comparison of the 0.03 and 0.1 mmol/kg gadobutrol doses and the 0.1 and 0.3 mmol/kg gadobutrol doses using detection of all comparator-detected matched lesions was performed for BR 3
Time Frame up to 2 hours after the injection of study medication
Hide Outcome Measure Data
Hide Analysis Population Description
PPS (excluding subjects with no lesion detected)
Arm/Group Title Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875) Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875) Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875)
Hide Arm/Group Description:
Participant received one dose of 0.03 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
Participant received one dose of 0.1 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
Participant received one dose of 0.3 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
Overall Number of Participants Analyzed 59 56 56
Measure Type: Number
Unit of Measure: percentage of lesions
63.31 57.18 50.05
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875), Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.11
Comments [Not Specified]
Method Chi-squared
Comments adjusted for clustering
Method of Estimation Estimation Parameter difference in accuracy
Estimated Value -6.13
Confidence Interval 95%
-13.73 to 1.48
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875), Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.55
Comments [Not Specified]
Method Chi-squared
Comments adjusted for clustering
Method of Estimation Estimation Parameter difference in accuracies
Estimated Value 2.87
Confidence Interval 95%
-6.59 to 12.32
Estimation Comments [Not Specified]
10.Secondary Outcome
Title Accuracy Comparison of Gadobutrol Doses - Detection of Matched Enhanced Lesions: Blinded Reader 1
Hide Description The percent accuracy (total number of lesions matching the comparator divided by the total number of lesions identified by gadobutrol) comparison of the 0.03 and 0.1 mmol/kg gadobutrol doses and the 0.1 and 0.3 mmol/kg gadobutrol doses using detection of all comparator-detected matched enhanced lesions was performed for BR 1
Time Frame up to 2 hours after the injection of study medication
Hide Outcome Measure Data
Hide Analysis Population Description
PPS (excluding subjects with no enhanced lesion detected)
Arm/Group Title Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875) Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875) Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875)
Hide Arm/Group Description:
Participant received one dose of 0.03 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
Participant received one dose of 0.1 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
Participant received one dose of 0.3 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
Overall Number of Participants Analyzed 52 48 50
Measure Type: Number
Unit of Measure: percentage of lesions
48.10 72.73 55.21
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875), Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.02
Comments [Not Specified]
Method Chi-squared
Comments adjusted for clustering
Method of Estimation Estimation Parameter difference in accuracy
Estimated Value 24.63
Confidence Interval 95%
5.39 to 43.86
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875), Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.13
Comments [Not Specified]
Method Chi-squared
Comments adjusted for clustering
Method of Estimation Estimation Parameter difference in accuracy
Estimated Value -10.75
Confidence Interval 95%
-24.41 to 2.90
Estimation Comments [Not Specified]
11.Secondary Outcome
Title Accuracy Comparison of Gadobutrol Doses - Detection of Matched Enhanced Lesions: Blinded Reader 2
Hide Description The percent accuracy (total number of lesions matching the comparator divided by the total number of lesions identified by gadobutrol) comparison of the 0.03 and 0.1 mmol/kg gadobutrol doses and the 0.1 and 0.3 mmol/kg gadobutrol doses using detection of all comparator-detected matched enhanced lesions was performed for BR 2
Time Frame up to 2 hours after the injection of study medication
Hide Outcome Measure Data
Hide Analysis Population Description
PPS (excluding subjects with no enhanced lesion detected)
Arm/Group Title Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875) Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875) Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875)
Hide Arm/Group Description:
Participant received one dose of 0.03 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
Participant received one dose of 0.1 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
Participant received one dose of 0.3 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
Overall Number of Participants Analyzed 47 44 44
Measure Type: Number
Unit of Measure: percentage of lesions
69.23 82.14 63.77
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875), Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.07
Comments [Not Specified]
Method Chi-squared
Comments adjusted for clustering
Method of Estimation Estimation Parameter difference in accuracy
Estimated Value 12.91
Confidence Interval 95%
-1.44 to 27.26
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875), Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.02
Comments [Not Specified]
Method Chi-squared
Comments adjusted for clustering
Method of Estimation Estimation Parameter difference in accuracy
Estimated Value -18.37
Confidence Interval 95%
-33.60 to -1.35
Estimation Comments [Not Specified]
12.Secondary Outcome
Title Accuracy Comparison of Gadobutrol Doses - Detection of Matched Enhanced Lesions: Blinded Reader 3
Hide Description The percent accuracy (total number of lesions matching the comparator divided by the total number of lesions identified by gadobutrol) comparison of the 0.03 and 0.1 mmol/kg gadobutrol doses and the 0.1 and 0.3 mmol/kg gadobutrol doses using detection of all comparator-detected matched enhanced lesions was performed for BR 3
Time Frame up to 2 hours after the injection of study medication
Hide Outcome Measure Data
Hide Analysis Population Description
PPS(excluding subjects with no enhanced lesion detected)
Arm/Group Title Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875) Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875) Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875)
Hide Arm/Group Description:
Participant received one dose of 0.03 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
Participant received one dose of 0.1 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
Participant received one dose of 0.3 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
Overall Number of Participants Analyzed 51 46 48
Measure Type: Number
Unit of Measure: percentage of lesions
55.07 73.53 68.24
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875), Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.02
Comments [Not Specified]
Method Chi-squared
Comments adjusted for clustering
Method of Estimation Estimation Parameter difference in accuracy
Estimated Value 18.46
Confidence Interval 95%
3.15 to 33.77
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875), Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.45
Comments [Not Specified]
Method Chi-squared
Comments adjusted for clustering
Method of Estimation Estimation Parameter difference in accuracy
Estimated Value -5.29
Confidence Interval 95%
-18.83 to 8.24
Estimation Comments [Not Specified]
13.Secondary Outcome
Title Evaluation of the Correct Diagnosis Following Gadobutrol-enhanced and Unenhanced MRI
Hide Description The gadobutrol-enhanced and unenhanced MRI diagnoses of the average reader were compared to the final diagnosis.
Time Frame up to 2 hours after the injection of study medication
Hide Outcome Measure Data
Hide Analysis Population Description
PPS
Arm/Group Title Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875) Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875) Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875)
Hide Arm/Group Description:
Participant received one dose of 0.03 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
Participant received one dose of 0.1 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
Participant received one dose of 0.3 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
Overall Number of Participants Analyzed 61 56 56
Measure Type: Number
Unit of Measure: percentage of exact matches
yes 62.3 57.1 54.2
no 37.7 42.9 45.8
14.Secondary Outcome
Title Evaluation of the Diagnostic Confidence Based on Unenhanced MRI and Combined Unenhanced and Enhanced MRI
Hide Description The diagnostic confidence, the level of certainty in a diagnosis, was determined based on the average of the blinded readers.
Time Frame up to 2 hours after the injection of study medication
Hide Outcome Measure Data
Hide Analysis Population Description
PPS, Due to rounding, the sum of the percentages may range from 99.9 to 100.1.
Arm/Group Title Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875) Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875) Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875)
Hide Arm/Group Description:
Participant received one dose of 0.03 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
Participant received one dose of 0.1 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
Participant received one dose of 0.3 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
Overall Number of Participants Analyzed 61 56 56
Measure Type: Number
Unit of Measure: percentage of participants
not confident 3.3 3.6 3.6
somewhat confident 23.0 28.6 23.2
confident 49.2 33.9 39.3
very confident 24.6 33.9 33.9
15.Secondary Outcome
Title Evaluation of Perfusion Map Quality (Uncorrected Cerebral Blood Volume [CBV]) - Blinded Reader 1
Hide Description BR 1 evaluated the visibility of the lesion(s) on the uncorrected CBV perfusion map.
Time Frame up to 2 hours after the injection of study medication
Hide Outcome Measure Data
Hide Analysis Population Description
PPS, Due to rounding, the sum of the percentages may range from 99.9 to 100.1.
Arm/Group Title Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875) Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875) Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875)
Hide Arm/Group Description:
Participant received one dose of 0.03 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
Participant received one dose of 0.1 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
Participant received one dose of 0.3 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
Overall Number of Participants Analyzed 61 56 56
Measure Type: Number
Unit of Measure: percentage of participants
Not Applicable (Appl.) 8.2 7.1 3.6
missing 1.6 0 0
not visible 16.4 10.7 21.4
poor 21.3 17.9 12.5
moderate 16.4 19.6 12.5
good 23 19.6 17.9
excellent 13.1 25 32.1
16.Secondary Outcome
Title Evaluation of Perfusion Map Quality (Uncorrected Cerebral Blood Volume (CBV)) - Blinded Reader 2
Hide Description BR 2 evaluated the visibility of the lesion(s) on the uncorrected CBV perfusion map.
Time Frame up to 2 hours after the injection of study medication
Hide Outcome Measure Data
Hide Analysis Population Description
PPS. Due to rounding, the sum of percentages may range from 99.9 to 100.1.
Arm/Group Title Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875) Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875) Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875)
Hide Arm/Group Description:
Participant received one dose of 0.03 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
Participant received one dose of 0.1 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
Participant received one dose of 0.3 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
Overall Number of Participants Analyzed 61 56 56
Measure Type: Number
Unit of Measure: percentage of participants
Not Appl. 9.8 10.7 10.7
missing 1.6 0 0
not visible 8.2 12.5 8.9
poor 27.9 12.5 12.5
moderate 24.6 21.4 16.1
good 19.7 23.2 26.8
excellent 8.2 19.6 25
17.Secondary Outcome
Title Evaluation of Perfusion Map Quality (Uncorrected Cerebral Blood Volume (CBV)) - Blinded Reader 3
Hide Description BR 3 evaluated the visibility of the lesion(s) on the uncorrected CBV perfusion map.
Time Frame up to 2 hours after the injection of study medication
Hide Outcome Measure Data
Hide Analysis Population Description
PPS. Due to rounding, the sum of the percentages may range from 99.9 to 100.1.
Arm/Group Title Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875) Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875) Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875)
Hide Arm/Group Description:
Participant received one dose of 0.03 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
Participant received one dose of 0.1 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
Participant received one dose of 0.3 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
Overall Number of Participants Analyzed 61 56 56
Measure Type: Number
Unit of Measure: percentage of participants
Not Appl. 11.5 8.9 16.1
missing 1.6 0 0
not visible 13.1 23.2 19.6
poor 23 12.5 12.5
moderate 26.2 23.2 16.1
good 16.4 12.5 10.7
excellent 8.2 19.6 25
18.Secondary Outcome
Title Evaluation of Perfusion Map Quality (Corrected Cerebral Blood Volume (CBV)) - Blinded Reader 1
Hide Description BR 1 evaluated the visibility of the lesion(s) on the corrected CBV perfusion map.
Time Frame up to 2 hours after the injection of study medication
Hide Outcome Measure Data
Hide Analysis Population Description
PPS. Due to rounding, the sum of the percentages may range from 99.9 to 100.1.
Arm/Group Title Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875) Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875) Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875)
Hide Arm/Group Description:
Participant received one dose of 0.03 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
Participant received one dose of 0.1 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
Participant received one dose of 0.3 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
Overall Number of Participants Analyzed 61 56 56
Measure Type: Number
Unit of Measure: percentage of participants
Not Appl. 8.2 10.7 3.6
missing 1.6 0 0
not visible 6.6 14.3 25
poor 24.6 19.6 10.7
moderate 21.3 8.9 8.9
good 19.7 21.4 30.4
excellent 18 25 21.4
19.Secondary Outcome
Title Evaluation of Perfusion Map Quality (Corrected Cerebral Blood Volume (CBV)) - Blinded Reader 2
Hide Description BR 2 evaluated the visibility of the lesion(s) on the corrected CBV perfusion map.
Time Frame up to 2 hours after the injection of study medication
Hide Outcome Measure Data
Hide Analysis Population Description
PPS. Due to rounding, the sum of the percentages may range from 99.9 to 100.1.
Arm/Group Title Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875) Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875) Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875)
Hide Arm/Group Description:
Participant received one dose of 0.03 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
Participant received one dose of 0.1 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
Participant received one dose of 0.3 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
Overall Number of Participants Analyzed 61 56 56
Measure Type: Number
Unit of Measure: percentage of participants
Not Appl. 11.5 16.1 7.1
missing 1.6 0 0
not visible 6.6 5.4 14.3
poor 21.3 14.3 7.1
moderate 23 21.4 14.3
good 26.2 17.9 32.1
excellent 9.8 25 25
20.Secondary Outcome
Title Evaluation of Perfusion Map Quality (Corrected Cerebral Blood Volume (CBV)) - Blinded Reader 3
Hide Description BR 3 evaluated the visibility of the lesion(s) on the corrected CBV perfusion map.
Time Frame up to 2 hours after the injection of study medication
Hide Outcome Measure Data
Hide Analysis Population Description
PPS. Due to rounding, the sum of the percentages may range from 99.9 to 100.1.
Arm/Group Title Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875) Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875) Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875)
Hide Arm/Group Description:
Participant received one dose of 0.03 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
Participant received one dose of 0.1 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
Participant received one dose of 0.3 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
Overall Number of Participants Analyzed 61 56 56
Measure Type: Number
Unit of Measure: percentage of participants
Not Appl. 11.5 12.5 17.9
missing 1.6 1.8 0
not visible 14.8 19.6 23.2
poor 24.6 12.5 10.7
moderate 19.7 17.9 10.7
good 21.3 16.1 23.2
excellent 6.6 19.6 14.3
21.Secondary Outcome
Title Evaluation of Perfusion Map Quality (Cerebral Blood Flow (CBF)) - Blinded Reader 1
Hide Description BR 1 evaluated the visibility of the lesion(s) on the CBF perfusion map.
Time Frame up to 2 hours after the injection of study medication
Hide Outcome Measure Data
Hide Analysis Population Description
PPS. Due to rounding, the sum of the percentages may range from 99.9 to 100.1.
Arm/Group Title Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875) Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875) Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875)
Hide Arm/Group Description:
Participant received one dose of 0.03 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
Participant received one dose of 0.1 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
Participant received one dose of 0.3 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
Overall Number of Participants Analyzed 61 56 56
Measure Type: Number
Unit of Measure: percentage of participants
Not Appl. 6.6 12.5 1.8
missing 1.6 0 0
not visible 13.1 14.3 23.2
poor 31.1 7.1 14.3
moderate 14.8 17.9 12.5
good 9.8 17.9 30.4
excellent 23 30.4 17.9
22.Secondary Outcome
Title Evaluation of Perfusion Map Quality (Cerebral Blood Flow (CBF)) - Blinded Reader 2
Hide Description BR 2 evaluated the visibility of the lesion(s) on the CBF perfusion map.
Time Frame up to 2 hours after the injection of study medication
Hide Outcome Measure Data
Hide Analysis Population Description
PPS. Due to rounding, the sum of the percentages may range from 99.9 to 100.1.
Arm/Group Title Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875) Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875) Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875)
Hide Arm/Group Description:
Participant received one dose of 0.03 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
Participant received one dose of 0.1 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
Participant received one dose of 0.3 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
Overall Number of Participants Analyzed 61 56 56
Measure Type: Number
Unit of Measure: percentage of participants
Not Appl. 8.2 12.5 8.9
missing 1.6 0 0
not visible 11.5 12.5 12.5
poor 21.3 8.9 19.6
moderate 23 25 25
good 24.6 16.1 8.9
excellent 9.8 25 25
23.Secondary Outcome
Title Evaluation of Perfusion Map Quality (Cerebral Blood Flow (CBF)) - Blinded Reader 3
Hide Description BR 3 evaluated the visibility of the lesion(s) on the CBF perfusion map.
Time Frame up to 2 hours after the injection of study medication
Hide Outcome Measure Data
Hide Analysis Population Description
PPS. Due to rounding, the sum of the percentages may range from 99.9 to 100.1.
Arm/Group Title Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875) Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875) Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875)
Hide Arm/Group Description:
Participant received one dose of 0.03 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
Participant received one dose of 0.1 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
Participant received one dose of 0.3 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
Overall Number of Participants Analyzed 61 56 56
Measure Type: Number
Unit of Measure: percentage of participants
Not Appl. 13.1 10.7 16.1
missing 1.6 1.8 0
not visible 14.8 17.9 25
poor 14.8 21.4 12.5
moderate 31.1 10.7 10.7
good 18 19.6 17.9
excellent 6.6 17.9 17.9
24.Secondary Outcome
Title Evaluation of Perfusion Map Quality (Time to Peak (TTP)) - Blinded Reader 1
Hide Description BR 1 evaluated the visibility of the lesion(s) on the TTP perfusion map.
Time Frame up to 2 hours after the injection of study medication
Hide Outcome Measure Data
Hide Analysis Population Description
PPS. Due to rounding, the sum of the percentages may range from 99.9 to 100.1.
Arm/Group Title Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875) Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875) Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875)
Hide Arm/Group Description:
Participant received one dose of 0.03 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
Participant received one dose of 0.1 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
Participant received one dose of 0.3 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
Overall Number of Participants Analyzed 61 56 56
Measure Type: Number
Unit of Measure: percentage of participants
Not Appl. 6.6 8.9 5.4
missing 1.6 1.8 0
not visible 34.4 21.4 26.8
poor 29.5 14.3 21.4
moderate 9.8 10.7 10.7
good 13.1 17.9 14.3
excellent 4.9 25 21.4
25.Secondary Outcome
Title Evaluation of Perfusion Map Quality (Time to Peak (TTP)) - Blinded Reader 2
Hide Description BR 2 evaluated the visibility of the lesion(s) on the TTP perfusion map.
Time Frame up to 2 hours after the injection of study medication
Hide Outcome Measure Data
Hide Analysis Population Description
PPS. Due to rounding, the sum of the percentages may range from 99.9 to 100.1.
Arm/Group Title Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875) Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875) Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875)
Hide Arm/Group Description:
Participant received one dose of 0.03 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
Participant received one dose of 0.1 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
Participant received one dose of 0.3 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
Overall Number of Participants Analyzed 61 56 56
Measure Type: Number
Unit of Measure: percentage of participants
Not Appl. 24.6 17.9 8.9
missing 1.6 0 0
not visible 18 5.4 14.3
poor 26.2 21.4 30.4
moderate 11.5 33.9 23.2
good 13.1 17.9 17.9
excellent 4.9 3.6 5.4
26.Secondary Outcome
Title Evaluation of Perfusion Map Quality (Time to Peak (TTP)) - Blinded Reader 3
Hide Description BR 3 evaluated the visibility of the lesion(s) on the TTP perfusion map.
Time Frame up to 2 hours after the injection of study medication
Hide Outcome Measure Data
Hide Analysis Population Description
PPS
Arm/Group Title Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875) Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875) Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875)
Hide Arm/Group Description:
Participant received one dose of 0.03 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
Participant received one dose of 0.1 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
Participant received one dose of 0.3 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
Overall Number of Participants Analyzed 61 56 56
Measure Type: Number
Unit of Measure: percentage of participants
Not Appl. 11.5 10.7 17.9
missing 1.6 1.8 0
not visible 32.8 25 21.4
poor 23 23.2 16.1
moderate 18 19.6 25
good 9.8 16.1 10.7
excellent 3.3 3.6 8.9
27.Secondary Outcome
Title Evaluation of Perfusion Map Quality (Mean Transit Time (MTT)) - Blinded Reader 1
Hide Description BR 1 evaluated the visibility of the lesion(s) on the MTT perfusion map.
Time Frame up to 2 hours after the injection of study medication
Hide Outcome Measure Data
Hide Analysis Population Description
PPS
Arm/Group Title Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875) Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875) Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875)
Hide Arm/Group Description:
Participant received one dose of 0.03 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
Participant received one dose of 0.1 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
Participant received one dose of 0.3 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
Overall Number of Participants Analyzed 61 56 56
Measure Type: Number
Unit of Measure: percentage of participants
Not Appl. 8.2 7.1 3.6
missing 1.6 0 0
not visible 16.4 16.1 19.6
poor 19.7 19.6 19.6
moderate 26.2 12.5 14.3
good 19.7 26.8 25
excellent 8.2 17.9 17.9
28.Secondary Outcome
Title Evaluation of Perfusion Map Quality (Mean Transit Time (MTT)) - Blinded Reader 2
Hide Description BR 2 evaluated the visibility of the lesion(s) on the MTT perfusion map.
Time Frame up to 2 hours after the injection of study medication
Hide Outcome Measure Data
Hide Analysis Population Description
PPS. Due to rounding, the sum of the percentages may range from 99.9 to 100.1.
Arm/Group Title Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875) Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875) Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875)
Hide Arm/Group Description:
Participant received one dose of 0.03 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
Participant received one dose of 0.1 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
Participant received one dose of 0.3 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
Overall Number of Participants Analyzed 61 56 56
Measure Type: Number
Unit of Measure: percentage of participants
Not Appl. 13.1 16.1 12.5
missing 1.6 0 0
not visible 14.8 14.3 14.3
poor 37.7 30.4 23.2
moderate 16.4 16.1 17.9
good 13.1 12.5 19.6
excellent 3.3 10.7 12.5
29.Secondary Outcome
Title Evaluation of Perfusion Map Quality (Mean Transit Time (MTT)) - Blinded Reader 3
Hide Description BR 3 evaluated the visibility of the lesion(s) on the MTT perfusion map.
Time Frame up to 2 hours after the injection of study medication
Hide Outcome Measure Data
Hide Analysis Population Description
PPS. Due to rounding, the sum of the percentages may range from 99.9 to 100.1.
Arm/Group Title Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875) Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875) Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875)
Hide Arm/Group Description:
Participant received one dose of 0.03 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
Participant received one dose of 0.1 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
Participant received one dose of 0.3 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
Overall Number of Participants Analyzed 61 56 56
Measure Type: Number
Unit of Measure: percentage of participants
Not Appl. 11.5 12.5 16.1
missing 1.6 1.8 0
not visible 19.7 25 21.4
poor 19.7 12.5 16.1
moderate 29.5 30.4 12.5
good 13.1 7.1 17.9
excellent 4.9 10.7 16.1
30.Secondary Outcome
Title Evaluation of Perfusion Map Quality (Permeability Factor (PF) - Blinded Reader 1
Hide Description BR 1 evaluated the visibility of the lesion(s) on the PF perfusion map.
Time Frame up to 2 hours after the injection of study medication
Hide Outcome Measure Data
Hide Analysis Population Description
PPS. Due to rounding, the sum of the percentages may range from 99.9 to 100.1.
Arm/Group Title Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875) Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875) Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875)
Hide Arm/Group Description:
Participant received one dose of 0.03 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
Participant received one dose of 0.1 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
Participant received one dose of 0.3 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
Overall Number of Participants Analyzed 61 56 56
Measure Type: Number
Unit of Measure: percentage of participants
Not Appl. 13.1 8.9 1.8
not visible 11.5 21.4 28.6
poor 21.3 23.2 19.6
moderate 13.1 7.1 17.9
good 19.7 21.4 17.9
excellent 21.3 17.9 14.3
31.Secondary Outcome
Title Evaluation of Perfusion Map Quality (Permeability Factor (PF) - Blinded Reader 2
Hide Description BR 2 evaluated the visibility of the lesion(s) on the PF perfusion map.
Time Frame up to 2 hours after the injection of study medication
Hide Outcome Measure Data
Hide Analysis Population Description
PPS. Due to rounding, the sum of the percentages may range from 99.9 to 100.1.
Arm/Group Title Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875) Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875) Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875)
Hide Arm/Group Description:
Participant received one dose of 0.03 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
Participant received one dose of 0.1 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
Participant received one dose of 0.3 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
Overall Number of Participants Analyzed 61 56 56
Measure Type: Number
Unit of Measure: percentage of participants
Not Appl. 14.8 16.1 8.9
missing 3.3 0 0
not visible 6.6 14.3 16.1
poor 21.3 17.9 16.1
moderate 26.2 28.6 25
good 19.7 16.1 26.8
excellent 8.2 7.1 7.1
32.Secondary Outcome
Title Evaluation of Perfusion Map Quality (Permeability Factor (PF)) - Blinded Reader 3
Hide Description BR 3 evaluated the visibility of the lesion(s) on the PF perfusion map.
Time Frame up to 2 hours after the injection of study medication
Hide Outcome Measure Data
Hide Analysis Population Description
PPS
Arm/Group Title Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875) Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875) Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875)
Hide Arm/Group Description:
Participant received one dose of 0.03 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
Participant received one dose of 0.1 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
Participant received one dose of 0.3 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
Overall Number of Participants Analyzed 61 56 56
Measure Type: Number
Unit of Measure: percentage of participants
Not Appl. 11.5 10.7 19.6
missing 4.9 3.6 0
not visible 13.1 26.8 25
poor 24.6 14.3 14.3
moderate 21.3 12.5 12.5
good 18 21.4 17.9
excellent 6.6 10.7 10.7
33.Secondary Outcome
Title Evaluation of Perfusion Map Parameter Value (Uncorrected Cerebral Blood Volume (CBV)) - Independent Radiologist
Hide Description The independent radiologist determined the uncorrected CBV for each lesion. CBV is the volume of blood in the tissue.
Time Frame up to 2 hours after the injection of study medication
Hide Outcome Measure Data
Hide Analysis Population Description
PPS (excluding subjects whose parameter map value was not determined)
Arm/Group Title Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875) Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875) Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875)
Hide Arm/Group Description:
Participant received one dose of 0.03 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
Participant received one dose of 0.1 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
Participant received one dose of 0.3 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
Overall Number of Participants Analyzed 55 45 42
Mean (Standard Deviation)
Unit of Measure: mL / 100 g tissue
114.61  (127.75) 346.81  (313.49) 1209.89  (1121.63)
34.Secondary Outcome
Title Evaluation of Perfusion Map Parameter Value (Corrected Cerebral Blood Volume (CBV)) - Independent Radiologist
Hide Description The independent radiologist determined the corrected CBV for each lesion. CBV is the volume of blood in the tissue.
Time Frame up to 2 hours after the injection of study medication
Hide Outcome Measure Data
Hide Analysis Population Description
PPS (excluding subjects whose parameter map value was not determined)
Arm/Group Title Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875) Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875) Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875)
Hide Arm/Group Description:
Participant received one dose of 0.03 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
Participant received one dose of 0.1 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
Participant received one dose of 0.3 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
Overall Number of Participants Analyzed 55 44 42
Mean (Standard Deviation)
Unit of Measure: mL / 100 g tissue
2728.71  (2788.59) 2682.97  (1493.95) 3382.20  (1908.56)
35.Secondary Outcome
Title Evaluation of Perfusion Map Parameter Value (Cerebral Blood Flow (CBF)) - Independent Radiologist
Hide Description The independent radiologist determined the CBF for each lesion. CBF is the volume of blood passing through tissue per unit of time.
Time Frame up to 2 hours after the injection of study medication
Hide Outcome Measure Data
Hide Analysis Population Description
PPS (excluding subjects whose parameter map value was not determined)
Arm/Group Title Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875) Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875) Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875)
Hide Arm/Group Description:
Participant received one dose of 0.03 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
Participant received one dose of 0.1 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
Participant received one dose of 0.3 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
Overall Number of Participants Analyzed 55 44 42
Mean (Standard Deviation)
Unit of Measure: mL / 100 g tissue / min.
4.80  (6.37) 5.15  (4.30) 3.48  (2.24)
36.Secondary Outcome
Title Evaluation of Perfusion Map Parameter Value (Time to Peak (TTP)) - Independent Radiologist
Hide Description The independent radiologist determined the TTP for each lesion. TTP is the delay between the arrival of the contrast agent bolus arrival time and the peak of the concentration curve.
Time Frame up to 2 hours after the injection of study medication
Hide Outcome Measure Data
Hide Analysis Population Description
PPS (excluding subjects whose parameter map value was not determined)
Arm/Group Title Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875) Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875) Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875)
Hide Arm/Group Description:
Participant received one dose of 0.03 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
Participant received one dose of 0.1 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
Participant received one dose of 0.3 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
Overall Number of Participants Analyzed 55 45 42
Mean (Standard Deviation)
Unit of Measure: seconds
79.39  (25.43) 80.31  (27.21) 86.52  (28.70)
37.Secondary Outcome
Title Evaluation of Perfusion Map Parameter Value (Mean Transit Time (MTT)) - Independent Radiologist
Hide Description The independent radiologist determined the MTT for each lesion. The MTT is the time (seconds) for contrast to pass through tissues.
Time Frame up to 2 hours after the injection of study medication
Hide Outcome Measure Data
Hide Analysis Population Description
PPS (excluding subjects whose parameter map value was not determined)
Arm/Group Title Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875) Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875) Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875)
Hide Arm/Group Description:
Participant received one dose of 0.03 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
Participant received one dose of 0.1 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
Participant received one dose of 0.3 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
Overall Number of Participants Analyzed 55 44 42
Mean (Standard Deviation)
Unit of Measure: seconds
6.30  (4.77) 6.02  (3.71) 7.05  (4.54)
38.Secondary Outcome
Title Evaluation of Perfusion Map Parameter Value (Permeability Factor (PF)) - Independent Radiologist
Hide Description The independent radiologist determined the PF for each lesion
Time Frame up to 2 hours after the injection of study medication
Hide Outcome Measure Data
Hide Analysis Population Description
PPS (excluding subjects whose parameter map value was not determined)
Arm/Group Title Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875) Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875) Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875)
Hide Arm/Group Description:
Participant received one dose of 0.03 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
Participant received one dose of 0.1 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
Participant received one dose of 0.3 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
Overall Number of Participants Analyzed 54 44 42
Mean (Standard Deviation)
Unit of Measure: seconds
4.04  (3.35) 1.65  (0.82) 0.99  (1.88)
39.Secondary Outcome
Title Evaluation of Perfusion Map Artifacts (Uncorrected Cerebral Blood Volume (CBV)) - Blinded Reader
Hide Description The blinded reader evaluated if artifacts were present on the uncorrected CBV perfusion map and recorded the type of the major artifact. EPI: echo-planar imaging; T2: transversal relaxation time.
Time Frame up to 2 hours after the injection of study medication
Hide Outcome Measure Data
Hide Analysis Population Description
PPS
Arm/Group Title Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875) Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875) Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875)
Hide Arm/Group Description:
Participant received one dose of 0.03 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
Participant received one dose of 0.1 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
Participant received one dose of 0.3 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
Overall Number of Participants Analyzed 61 56 56
Measure Type: Number
Unit of Measure: percentage of participants
Blinded Reader 1 - Missing 1.6 0 0
Blinded Reader 1 - 0 none 72.1 75 69.6
Blinded Reader 1 - EPI distortion 24.6 23.2 21.4
Blinded Reader 1 - movement artifacts 0 0 1.8
Blinded Reader 1 - other 1.6 1.8 7.1
Blinded reader 2 - Missing 1.6 0 0
Blinded Reader 2 - 0 none 62.3 66.1 89.3
Blinded Reader 2 - EPI distortion 3.3 10.7 5.4
Blinded Reader 2 - movement artifacts 32.8 23.2 3.6
Blinded Reader 2 - other 0 0 1.8
Blinded Reader 3 - Missing 1.6 0 0
Blinded Reader 3 - none 62.3 67.9 78.6
Blinded Reader 3 - EPI distortion 6.6 16.1 10.7
Blinded Reader 3 - T2 artifacts 3.3 10.7 3.6
Blinded Reader 3 - movement artifacts 14.8 3.6 3.6
Blinded Reader 3 - other 11.5 1.8 3.6
40.Secondary Outcome
Title Evaluation of Perfusion Map Artifacts (Corrected Cerebral Blood Volume (CBV)) - Blinded Reader
Hide Description The blinded reader evaluated if artifacts were present on the corrected CBV perfusion map and recorded the type of the major artifact. EPI: echo-planar imaging; T2: transversal relaxation time. CBV is the fraction of the tissue volume occupied by the blood.
Time Frame up to 2 hours after the injection of study medication
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PPS
Arm/Group Title Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875) Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875) Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875)
Hide Arm/Group Description:
Participant received one dose of 0.03 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
Participant received one dose of 0.1 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
Participant received one dose of 0.3 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
Overall Number of Participants Analyzed 61 56 56
Measure Type: Number
Unit of Measure: percentage of participants
Blinded Reader 1 - Missing 1.6 0 0
Blinded Reader 1 - 0 none 75.4 76.8 66.1
Blinded Reader 1 - EPI distortion 21.3 23.2 28.6
Blinded Reader 1 - other 1.6 0 5.4
Blinded Reader 2 - Missing 1.6 0 0
Blinded Reader 2 - 0 none 78.7 80.4 83.9
Blinded Reader 2 - EPI distortion 6.6 8.9 14.3
Blinded Reader 2 - movement artifacts 13.1 10.7 0
Blinded Reader 2 - other 0 0 1.8
Blinded Reader 3 - Missing 1.6 1.8 0
Blinded Reader 3 - 0 none 55.7 69.6 76.8
Blinded Reader 3 - EPI distortion 4.9 12.5 12.5
Blinded Reader 3 - T2 artifacts 6.6 10.7 3.6
Blinded Reader 3 - movement artifacts 23 1.8 1.8
Blinded Reader 3 - other 8.2 3.6 5.4
41.Secondary Outcome
Title Evaluation of Perfusion Map Artifacts (Cerebral Blood Flow (CBF)) - Blinded Reader
Hide Description The blinded reader evaluated if artifacts were present on the CBF perfusion map and recorded the type of the major artifact. EPI: echo-planar imaging; T2: transversal relaxation time
Time Frame up to 2 hours after the injection of study medication
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PPS
Arm/Group Title Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875) Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875) Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875)
Hide Arm/Group Description:
Participant received one dose of 0.03 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
Participant received one dose of 0.1 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
Participant received one dose of 0.3 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
Overall Number of Participants Analyzed 61 56 56
Measure Type: Number
Unit of Measure: percentage of participants
Blinded Reader 1 - Missing 1.6 0 0
Blinded Reader 1 - 0 none 70.5 85.7 71.4
Blinded Reader 1 - EPI distortion 26.2 12.5 23.2
Blinded Reader 1 - T2 artifacts 1.6 0 0
Blinded Reader 1 - other 0 1.8 5.4
Blinded Reader 2- Missing 1.6 0 0
Blinded Reader 2- 0 none 77 82.1 80.4
Blinded Reader 2 - EPI distortion 6.6 7.1 10.7
Blinded Reader 2- movement artifacts 14.8 10.7 7.1
Blinded Reader 2- other 0 0 1.8
Blinded Reader 3 - Missing 1.6 1.8 0
Blinded Reader 3 - 0 none 68.9 76.8 75
Blinded Reader 3 - EPI distortion 6.6 10.7 12.5
Blinded Reader 3 - T2 artifacts 11.5 8.9 8.9
Blinded Reader 3 - movement artifacts 3.3 1.8 0
Blinded Reader 3 - other 8.2 0 3.6
42.Secondary Outcome
Title Evaluation of Perfusion Map Artifacts (Time to Peak (TTP)) - Blinded Reader
Hide Description The blinded reader evaluated if artifacts were present on the TTP perfusion map and recorded the type of the major artifact. EPI: echo-planar imaging; T2: transversal relaxation time
Time Frame up to 2 hours after the injection of study medication
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PPS
Arm/Group Title Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875) Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875) Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875)
Hide Arm/Group Description:
Participant received one dose of 0.03 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
Participant received one dose of 0.1 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
Participant received one dose of 0.3 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
Overall Number of Participants Analyzed 61 56 56
Measure Type: Number
Unit of Measure: percentage of participants
Blinded Reader 1 - missing 1.6 1.8 0
Blinded Reader 1 - 0 none 75.4 76.8 75
Blinded Reader 1 - EPI distortion 14.8 21.4 19.6
Blinded Reader 1- movement artifacts 1.6 0 0
Blinded Reader 1 - other 6.6 0 5.4
Blinded Reader 2 - missing 1.6 0 0
Blinded Reader 2 - 0 none 34.4 62.5 71.4
Blinded Reader 2 - EPI distortion 6.6 8.9 10.7
Blinded Reader 2 - movement artifacts 37.7 19.6 17.9
Blinded Reader 2 - other 19.7 8.9 0
Blinded Reader 3 - missing 1.6 1.8 0
Blinded Reader 3 - 0 none 41 57.1 64.3
Blinded Reader 3 - EPI distortions 4.9 10.7 12.5
Blinded Reader 3 - T2 artifacts 3.3 8.9 8.9
Blinded Reader3 - movement artifacts 26.2 5.4 7.1
Blinded Reader 3 - other 23 16.1 7.1
43.Secondary Outcome
Title Evaluation of Perfusion Map Artifacts (Mean Transit Time (MTT)) - Blinded Reader
Hide Description The blinded reader evaluated if artifacts were present on the MTT perfusion map and recorded the type of the major artifact. EPI: echo-planar imaging; T2: transversal relaxation time
Time Frame up to 2 hours after the injection of study medication
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PPS
Arm/Group Title Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875) Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875) Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875)
Hide Arm/Group Description:
Participant received one dose of 0.03 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
Participant received one dose of 0.1 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
Participant received one dose of 0.3 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
Overall Number of Participants Analyzed 61 56 56
Measure Type: Number
Unit of Measure: percentage of participants
Blinded Reader 1 - missing 1.6 0 0
Blinded Reader 1 - 0 none 80.3 67.9 71.4
Blinded Reader 1 - EPI distortion 16.4 30.4 19.6
Blinded Reader 1 - T2 artifacts 0 0 1.8
Blinded Reader 1 - movement artifacts 0 0 1.8
Blinded Reader 1 - other 1.6 1.8 5.4
Blinded Reader 2 - missing 1.6 0 0
Blinded Reader 2 - none 41 71.4 73.2
Blinded Reader 2 - EPI distortion 1.6 5.4 8.9
Blinded Reader 2 - movement artifacts 52.5 23.2 16.1
Blinded Reader 2 - other 3.3 0 1.8
Blinded Reader 3 - missing 1.6 1.8 0
Blinded Reader 3 - 0 none 50.8 66.1 69.6
Blinded Reader 3 - EPI distortion 8.2 7.1 16.1
Blinded Reader 3 - T2 artifacts 3.3 5.4 5.4
Blinded Reader 3 - movement artifacts 26.2 10.7 5.4
Blinded Reader 3 - other 9.8 8.9 3.6
44.Secondary Outcome
Title Evaluation of Perfusion Map Artifacts (Permeability Factor (PF)) - Blinded Reader
Hide Description The blinded reader evaluated if artifacts were present on the PF perfusion map and recorded the type of the major artifact. EPI: echo-planar imaging; T2: transversal relaxation time
Time Frame up to 2 hours after the injection of study medication
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Hide Analysis Population Description
PPS
Arm/Group Title Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875) Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875) Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875)
Hide Arm/Group Description:
Participant received one dose of 0.03 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
Participant received one dose of 0.1 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
Participant received one dose of 0.3 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
Overall Number of Participants Analyzed 61 56 56
Measure Type: Number
Unit of Measure: percentage of participants
Blinded Reader 1 - 0 none 73.8 75 71.4
Blinded Reader 1 - EPI distortion 21.3 23.2 26.8
Blinded Reader 1 - T2 artifacts 0 1.8 0
Blinded Reader 1 - movement artifacts 1.6 0 0
Blinded Reader 1 - other 3.3 0 1.8
Blinded Reader 2 - missing 3.3 0 0
Blinded Reader 2 - 0 none 73.8 75 73.2
Blinded Reader 2 - EPI distortion 4.9 8.9 12.5
Blinded Reader 2 - movement artifacts 16.4 16.1 14.3
Blinded Reader 2 - other 1.6 0 0
Blinded Reader 3 - missing 4.9 3.6 0
Blinded Reader 3 - 0 none 37.7 51.8 69.6
Blinded Reader 3 - EPI distortion 8.2 10.7 12.5
Blinded Reader 3 - T2 artifacts 4.9 10.7 5.4
Blinded Reader 3 - movement artifacts 36.1 14.3 7.1
Blinded Reader 3 - other 8.2 8.9 5.4
45.Secondary Outcome
Title Evaluation of MRI Tumor Grade Agreement With Biopsy Results by Dose Group
Hide Description The blinded readers gave an estimation of the tumor grade of brain tumors (low grade [I or II] or high grade [III or IV]) in terms of malignancy using the information obtained by perfusion imaging, which was compared to the biopsy sample results
Time Frame up to 2 hours after the injection of study medication
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PPS participants with tumors
Arm/Group Title Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875) Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875) Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875)
Hide Arm/Group Description:
Participant received one dose of 0.03 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
Participant received one dose of 0.1 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
Participant received one dose of 0.3 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
Overall Number of Participants Analyzed 61 55 56
Measure Type: Number
Unit of Measure: Percentage of accuracy
Blinded Reader 1 60.0 57.1 40.0
Blinded Reader 2 40.0 42.9 40.0
Blinded Reader 3 60.0 57.1 30.0
46.Secondary Outcome
Title Contrast to Noise Ratio (CNR) of Lesion/Gray Matter and Lesion/White Matter
Hide Description CNR between lesion/gray matter and lesion/white matter in the perfusion imaging was defined as the signal intensity (SI) difference between lesion and gray or white matter divided by the standard deviation of background noise. An independent radiologist evaluated the gadobutrol-enhanced perfusion MRI for signal intensity.
Time Frame up to 2 hours after the injection of study medication
Hide Outcome Measure Data
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PPS (excluding subjects who had no lesion detected, and those who had no value determined)
Arm/Group Title Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875) Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875) Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875)
Hide Arm/Group Description:
Participant received one dose of 0.03 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
Participant received one dose of 0.1 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
Participant received one dose of 0.3 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
Overall Number of Participants Analyzed 48 44 39
Mean (Standard Deviation)
Unit of Measure: CNR
lesion gray -0.03  (13.0) 13.0  (78.4) 5.38  (25.0)
lesion white -10  (12) -17  (19.9) -17  (20.4)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875) Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875) Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875) Optimark~0.1mmol/kg BW
Hide Arm/Group Description Reporting Group 1 (RG1): Participant received one dose of 0.03 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate. Reporting group 2 (RG2): Participant received one dose of 0.1 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate. Reporting group 3 (RG3): Participant received one dose of 0.3 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate. Reporting group 4 (RG4): Participant received one dose of 0.1 mmol/kg BW of OptiMARK. OptiMARK was administered via a power injector at a rate of 2 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
All-Cause Mortality
Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875) Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875) Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875) Optimark~0.1mmol/kg BW
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/-- 
Hide Serious Adverse Events
Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875) Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875) Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875) Optimark~0.1mmol/kg BW
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/67 (0.00%)   1/90 (1.11%)   0/68 (0.00%)   1/227 (0.44%) 
Nervous system disorders         
Brain oedema * 1  0/67 (0.00%)  1/90 (1.11%)  0/68 (0.00%)  0/227 (0.00%) 
Intracranial pressure increased * 1  0/67 (0.00%)  1/90 (1.11%)  0/68 (0.00%)  0/227 (0.00%) 
Neurological symptom * 1  0/67 (0.00%)  1/90 (1.11%)  0/68 (0.00%)  0/227 (0.00%) 
Surgical and medical procedures         
Hospitalisation * 1  0/67 (0.00%)  0/90 (0.00%)  0/68 (0.00%)  1/227 (0.44%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA v9.1
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875) Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875) Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875) Optimark~0.1mmol/kg BW
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   19/67 (28.36%)   30/90 (33.33%)   22/68 (32.35%)   23/227 (10.13%) 
Eye disorders         
Conjunctivitis * 1  0/67 (0.00%)  0/90 (0.00%)  1/68 (1.47%)  0/227 (0.00%) 
Gastrointestinal disorders         
Abdominal pain lower * 1  1/67 (1.49%)  0/90 (0.00%)  0/68 (0.00%)  0/227 (0.00%) 
Cheilitis * 1  0/67 (0.00%)  1/90 (1.11%)  0/68 (0.00%)  0/227 (0.00%) 
Constipation * 1  1/67 (1.49%)  0/90 (0.00%)  0/68 (0.00%)  0/227 (0.00%) 
Diarrhoea * 1  0/67 (0.00%)  1/90 (1.11%)  2/68 (2.94%)  2/227 (0.88%) 
Dry mouth * 1  0/67 (0.00%)  1/90 (1.11%)  0/68 (0.00%)  0/227 (0.00%) 
Dyspepsia * 1  0/67 (0.00%)  1/90 (1.11%)  0/68 (0.00%)  0/227 (0.00%) 
Faeces discoloured * 1  1/67 (1.49%)  0/90 (0.00%)  0/68 (0.00%)  0/227 (0.00%) 
Gastrointestinal haemorrhage * 1  0/67 (0.00%)  0/90 (0.00%)  1/68 (1.47%)  0/227 (0.00%) 
Hypoaesthesia oral * 1  0/67 (0.00%)  1/90 (1.11%)  0/68 (0.00%)  0/227 (0.00%) 
Nausea * 1  0/67 (0.00%)  3/90 (3.33%)  1/68 (1.47%)  3/227 (1.32%) 
Stomach discomfort * 1  1/67 (1.49%)  0/90 (0.00%)  0/68 (0.00%)  0/227 (0.00%) 
Vomiting * 1  0/67 (0.00%)  1/90 (1.11%)  1/68 (1.47%)  0/227 (0.00%) 
General disorders         
Application site erythema * 1  0/67 (0.00%)  0/90 (0.00%)  1/68 (1.47%)  0/227 (0.00%) 
Asthenia * 1  1/67 (1.49%)  1/90 (1.11%)  0/68 (0.00%)  0/227 (0.00%) 
Chest pain * 1  0/67 (0.00%)  0/90 (0.00%)  1/68 (1.47%)  0/227 (0.00%) 
Chills * 1  0/67 (0.00%)  1/90 (1.11%)  0/68 (0.00%)  0/227 (0.00%) 
Feeling hot * 1  0/67 (0.00%)  0/90 (0.00%)  2/68 (2.94%)  0/227 (0.00%) 
Influenza like illness * 1  0/67 (0.00%)  0/90 (0.00%)  1/68 (1.47%)  0/227 (0.00%) 
Injection site erythema * 1  0/67 (0.00%)  1/90 (1.11%)  0/68 (0.00%)  2/227 (0.88%) 
Injection site irritation * 1  1/67 (1.49%)  0/90 (0.00%)  0/68 (0.00%)  0/227 (0.00%) 
Injection site pain * 1  0/67 (0.00%)  2/90 (2.22%)  0/68 (0.00%)  0/227 (0.00%) 
Malaise * 1  0/67 (0.00%)  1/90 (1.11%)  0/68 (0.00%)  0/227 (0.00%) 
Oedema peripheral * 1  0/67 (0.00%)  0/90 (0.00%)  1/68 (1.47%)  1/227 (0.44%) 
Vessel puncture site bruise * 1  0/67 (0.00%)  0/90 (0.00%)  1/68 (1.47%)  0/227 (0.00%) 
Infections and infestations         
Gastroenteritis viral * 1  0/67 (0.00%)  0/90 (0.00%)  1/68 (1.47%)  0/227 (0.00%) 
Urinary tract infection * 1  1/67 (1.49%)  0/90 (0.00%)  1/68 (1.47%)  1/227 (0.44%) 
Injury, poisoning and procedural complications         
Contusion * 1  2/67 (2.99%)  0/90 (0.00%)  0/68 (0.00%)  0/227 (0.00%) 
Investigations         
Blood sodium decreased * 1  0/67 (0.00%)  1/90 (1.11%)  0/68 (0.00%)  0/227 (0.00%) 
Electrocardiogram ST segment depression * 1  1/67 (1.49%)  0/90 (0.00%)  0/68 (0.00%)  0/227 (0.00%) 
Heart rate increased * 1  0/67 (0.00%)  1/90 (1.11%)  0/68 (0.00%)  0/227 (0.00%) 
Protein urine present * 1  0/67 (0.00%)  0/90 (0.00%)  1/68 (1.47%)  0/227 (0.00%) 
Metabolism and nutrition disorders         
Hypoglycaemia * 1  1/67 (1.49%)  0/90 (0.00%)  0/68 (0.00%)  0/227 (0.00%) 
Musculoskeletal and connective tissue disorders         
Muscle spasms * 1  0/67 (0.00%)  0/90 (0.00%)  1/68 (1.47%)  1/227 (0.44%) 
Muscular weakness * 1  0/67 (0.00%)  1/90 (1.11%)  0/68 (0.00%)  0/227 (0.00%) 
Pain in extremity * 1  0/67 (0.00%)  1/90 (1.11%)  0/68 (0.00%)  0/227 (0.00%) 
Nervous system disorders         
Burning sensation * 1  1/67 (1.49%)  0/90 (0.00%)  0/68 (0.00%)  0/227 (0.00%) 
Cerebellar syndrome * 1  0/67 (0.00%)  1/90 (1.11%)  0/68 (0.00%)  0/227 (0.00%) 
Convulsion * 1  0/67 (0.00%)  0/90 (0.00%)  1/68 (1.47%)  0/227 (0.00%) 
Dizziness * 1  2/67 (2.99%)  2/90 (2.22%)  1/68 (1.47%)  4/227 (1.76%) 
Dysgeusia * 1  0/67 (0.00%)  2/90 (2.22%)  0/68 (0.00%)  1/227 (0.44%) 
Headache * 1  8/67 (11.94%)  7/90 (7.78%)  3/68 (4.41%)  8/227 (3.52%) 
Paraesthesia * 1  0/67 (0.00%)  0/90 (0.00%)  2/68 (2.94%)  2/227 (0.88%) 
Paraparesis * 1  0/67 (0.00%)  1/90 (1.11%)  0/68 (0.00%)  0/227 (0.00%) 
Petit mal epilepsy * 1  0/67 (0.00%)  1/90 (1.11%)  0/68 (0.00%)  0/227 (0.00%) 
Somnolence * 1  1/67 (1.49%)  1/90 (1.11%)  1/68 (1.47%)  0/227 (0.00%) 
Psychiatric disorders         
Claustrophobia * 1  0/67 (0.00%)  0/90 (0.00%)  1/68 (1.47%)  1/227 (0.44%) 
Insomnia * 1  1/67 (1.49%)  0/90 (0.00%)  0/68 (0.00%)  0/227 (0.00%) 
Renal and urinary disorders         
Bladder discomfort * 1  0/67 (0.00%)  0/90 (0.00%)  1/68 (1.47%)  0/227 (0.00%) 
Dysuria * 1  2/67 (2.99%)  0/90 (0.00%)  0/68 (0.00%)  0/227 (0.00%) 
Reproductive system and breast disorders         
Galactorrhoea * 1  0/67 (0.00%)  0/90 (0.00%)  1/68 (1.47%)  0/227 (0.00%) 
Respiratory, thoracic and mediastinal disorders         
Cough * 1  0/67 (0.00%)  1/90 (1.11%)  1/68 (1.47%)  0/227 (0.00%) 
Dysphonia * 1  0/67 (0.00%)  1/90 (1.11%)  0/68 (0.00%)  0/227 (0.00%) 
Dyspnoea * 1  0/67 (0.00%)  1/90 (1.11%)  1/68 (1.47%)  0/227 (0.00%) 
Haemoptysis * 1  0/67 (0.00%)  0/90 (0.00%)  1/68 (1.47%)  0/227 (0.00%) 
Hiccups * 1  1/67 (1.49%)  0/90 (0.00%)  0/68 (0.00%)  0/227 (0.00%) 
Pharyngolaryngeal pain * 1  0/67 (0.00%)  1/90 (1.11%)  0/68 (0.00%)  0/227 (0.00%) 
Skin and subcutaneous tissue disorders         
Dermatitis allergic * 1  0/67 (0.00%)  1/90 (1.11%)  0/68 (0.00%)  0/227 (0.00%) 
Dry skin * 1  0/67 (0.00%)  0/90 (0.00%)  1/68 (1.47%)  0/227 (0.00%) 
Erythema * 1  1/67 (1.49%)  1/90 (1.11%)  0/68 (0.00%)  1/227 (0.44%) 
Hyperhidrosis * 1  0/67 (0.00%)  1/90 (1.11%)  0/68 (0.00%)  0/227 (0.00%) 
Rash * 1  0/67 (0.00%)  1/90 (1.11%)  0/68 (0.00%)  2/227 (0.88%) 
Vascular disorders         
Hot flush * 1  0/67 (0.00%)  0/90 (0.00%)  1/68 (1.47%)  0/227 (0.00%) 
Hyperaemia * 1  0/67 (0.00%)  1/90 (1.11%)  0/68 (0.00%)  0/227 (0.00%) 
Hypertension * 1  1/67 (1.49%)  0/90 (0.00%)  0/68 (0.00%)  0/227 (0.00%) 
Hypotension * 1  1/67 (1.49%)  0/90 (0.00%)  0/68 (0.00%)  0/227 (0.00%) 
Orthostatic hypotension * 1  1/67 (1.49%)  0/90 (0.00%)  0/68 (0.00%)  0/227 (0.00%) 
Thrombophlebitis * 1  0/67 (0.00%)  1/90 (1.11%)  0/68 (0.00%)  0/227 (0.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA v9.1
OptiMARK was used as a standard of reference in this study. A formal comparison of the efficacy of gadobutrol and OptiMARK was not specified prospectively in the statistical analysis plan. For completeness, the safety data of OptiMARK is presented.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Publication of results will be a group publication. Sites with recruitment of >= 6 valid patients will contribute. There will be one author from each site having contributed >= 6 valid patients. Authorship listed according to recruitment. Sponsor will appoint up to 3 persons as co-authors. Main author of publication may be announced by site with most valid patients enrolled. In case more than 1 center reaches maximum patient No., main author will be from the center with fastest recruitment
Results Point of Contact
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Name/Title: Therapeutic Area Head
Organization: BAYER
EMail: clinical-trials-contact@bayerhealthcare.com
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Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT00862459    
Other Study ID Numbers: 91400
308200 ( Other Identifier: company internal )
First Submitted: November 26, 2008
First Posted: March 17, 2009
Results First Submitted: September 14, 2011
Results First Posted: January 30, 2012
Last Update Posted: January 13, 2014