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Trial record 5 of 96 for:    gadobenate dimeglumine

Multihance at 3 Tesla in Brain Tumors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00395863
Recruitment Status : Completed
First Posted : November 6, 2006
Results First Posted : July 31, 2009
Last Update Posted : April 14, 2015
Sponsor:
Information provided by (Responsible Party):
Bracco Diagnostics, Inc

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Diagnostic
Condition Brain Tumor
Interventions Drug: Multihance
Drug: Arm 2 - Magnevist
Enrollment 46
Recruitment Details A total of 47 patients were recruited from March 2007 through February 2008 at 8 clinical trial sites. from Feb/18/2008 to Feb/22/2008, an off-site assessment of the images was performed by 3 board-certified radiologists who were blinded to which contrast agent was used, any patient's clinical information & any results from other imaging studies.
Pre-assignment Details 47 patients enrolled (signed informed consent); 46 were randomized and dosed.
Arm/Group Title MultiHance, Then Magnevist Magnevist, Then MultiHance
Hide Arm/Group Description 0.1 mmol/kg injection of each product 0.1 mmol/kg injection of each product
Period Title: Overall Study
Started 23 23
Completed 21 20
Not Completed 2 3
Reason Not Completed
Patients did not complete both exams             2             3
Arm/Group Title MultiHance, Then Magnevist Magnevist, Then MultiHance Total
Hide Arm/Group Description 0.1 mmol/kg injection of each product 0.1 mmol/kg injection of each product Total of all reporting groups
Overall Number of Baseline Participants 23 23 46
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 23 participants 23 participants 46 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
19
  82.6%
20
  87.0%
39
  84.8%
>=65 years
4
  17.4%
3
  13.0%
7
  15.2%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 23 participants 23 participants 46 participants
50.79  (15.497) 48.08  (16.064) 49.43  (15.667)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 23 participants 23 participants 46 participants
Female
12
  52.2%
9
  39.1%
21
  45.7%
Male
11
  47.8%
14
  60.9%
25
  54.3%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 23 participants 23 participants 46 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
3
  13.0%
3
   6.5%
White
23
 100.0%
19
  82.6%
42
  91.3%
More than one race
0
   0.0%
1
   4.3%
1
   2.2%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 23 participants 23 participants 46 participants
23 23 46
1.Primary Outcome
Title Global Diagnostic Preference Between the Two Exams
Hide Description Assessed by 3 blinded Readers for each of the 41 patients who had both MultiHance and Magnevist post dose MRI exam to assess whether the image with MultiHance was preferreed, both contrast agents were equal, or the image with Magnevist was preferred.
Time Frame Postdose Images for MultiHance Exam and for Magnevist Exam Compared
Hide Outcome Measure Data
Hide Analysis Population Description
Include all ITT population. The number of units analyzed is the total number of technically adequate postdose images assessed by the reader from the total number of participants with both MultiHance- and Magnevist-enhanced images. Patient-level analysis.
Arm/Group Title Reader 1 Reader 2 Reader 3
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 41 41 41
Overall Number of Units Analyzed
Type of Units Analyzed: Contrast-enhanced Images
41 41 41
Measure Type: Number
Unit of Measure: Contrast-enhanced Images
MultiHance Preferred 22 21 27
Contrast Agents Equal 19 19 14
Magnevist Preffered 0 1 0
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Reader 1, Reader 2, Reader 3
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.0001
Comments Reader 1
Method wilcoxon signed-rank test
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Reader 1, Reader 2, Reader 3
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Reader 2
Method wilcoxon signed-rank test
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Reader 1, Reader 2, Reader 3
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.0001
Comments Reader 3
Method wilcoxon signed-rank test
Comments [Not Specified]
2.Secondary Outcome
Title Lesion Border Delineation
Hide Description Assessed by 3 blinded Readers for each of the 41 patients who had both MultiHance and Magnevist post dose MRI exam to assess whether the image with MultiHance was preferreed, both contrast agents were equal, or the image with Magnevist was preferred.
Time Frame Postdose Images for MultiHance Exam and for Magnevist Exam Compared
Hide Outcome Measure Data
Hide Analysis Population Description
Include all ITT population. The number of units analyzed is the total number of technically adequate postdose images assessed by the reader from the total number of participants with both MultiHance- and Magnevist-enhanced images. Patient-level analysis.
Arm/Group Title Reader 1 Reader 2 Reader 3
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 41 41 41
Overall Number of Units Analyzed
Type of Units Analyzed: Contrast-enhanced Images
41 41 41
Measure Type: Number
Unit of Measure: Contrast-enhanced Images
MultiHance Preferred 14 11 13
Contrast Agents Equal 27 30 28
Magnevist Preferred 0 0 0
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Reader 1, Reader 2, Reader 3
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0001
Comments Reader 1
Method wilcoxon signed-rank test
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Reader 1, Reader 2, Reader 3
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.001
Comments Reader 2
Method wilcoxon signed-rank test
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Reader 1, Reader 2, Reader 3
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0002
Comments Reader 3
Method wilcoxon signed-rank test
Comments [Not Specified]
3.Secondary Outcome
Title Lesion Contrast Enhancement Between the Two Exams
Hide Description Assessed by 3 blinded Readers for each of the 41 patients who had both MultiHance and Magnevist post dose MRI exam to assess whether the image with MultiHance was preferreed, both contrast agents were equal, or the image with Magnevist was preferred.
Time Frame Postdose Images for MultiHance Exam and for Magnevist Exam Compared
Hide Outcome Measure Data
Hide Analysis Population Description
Include all ITT population. The number of units analyzed is the total number of technically adequate postdose images assessed by the reader from the total number of participants with both MultiHance- and Magnevist-enhanced images. Patient-level analysis.
Arm/Group Title Reader 1 Reader 2 Reader 3
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 41 41 41
Overall Number of Units Analyzed
Type of Units Analyzed: Contrast-enhanced Images
41 41 41
Measure Type: Number
Unit of Measure: Contrast-enhanced Images
MultiHance Preferred 22 20 22
Contrast Agents Equal 19 20 18
Magnevist Preferred 0 1 1
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Reader 1, Reader 2, Reader 3
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Reader 1
Method wilcoxon signed-rank test
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Reader 1, Reader 2, Reader 3
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Reader 2
Method wilcoxon signed-rank test
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Reader 1, Reader 2, Reader 3
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Reader 3
Method wilcoxon signed-rank test
Comments [Not Specified]
4.Secondary Outcome
Title Lesion-to-brain Ratio (LBR) for Each Lesion - Reader 1
Hide Description Change from predose to postdose in lesion-to-brain ratio computed. Comparison of the differences in change were analyzed.
Time Frame Predose and immediately postdose
Hide Outcome Measure Data
Hide Analysis Population Description
Include all ITT population. The number of units analyzed are the total number of lesions assessed by the reader from the total number of participants. Lesion-level analysis.
Arm/Group Title MultiHance Magnevist
Hide Arm/Group Description:
0.1 mmol/kg injection
0.1 mmol/kg injection
Overall Number of Participants Analyzed 41 41
Overall Number of Units Analyzed
Type of Units Analyzed: Lesions
27 27
Mean (Standard Deviation)
Unit of Measure: [ratio]
Predose 0.82  (0.17) 0.85  (0.19)
Postdose 1.50  (0.30) 1.31  (0.21)
Change from Baseline 0.68  (0.33) 0.46  (0.24)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection MultiHance, Magnevist
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Mean difference of MultiHance minus Magnevist for change from baseline
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.22
Confidence Interval 95%
0.14 to 0.30
Parameter Dispersion
Type: Standard Deviation
Value: 0.22
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Lesion-to-brain Ratio (LBR) for Each Lesion - Reader 2
Hide Description Change from predose to postdose in lesion-to-brain ratio computed. Comparison of the differences in change were analyzed.
Time Frame Predose and immediately postdose
Hide Outcome Measure Data
Hide Analysis Population Description
Include all ITT population. The number of units analyzed are the total number of lesions assessed by the reader from the total number of participants. Lesion-level analysis.
Arm/Group Title MultiHance Magnevist
Hide Arm/Group Description:
0.1 mmol/kg injection
0.1 mmol/kg injection
Overall Number of Participants Analyzed 41 41
Overall Number of Units Analyzed
Type of Units Analyzed: Lesions
25 25
Mean (Standard Deviation)
Unit of Measure: [ratio]
Predose 0.82  (0.18) 0.87  (0.17)
Postdose 1.61  (0.28) 1.36  (0.22)
Change from Baseline 0.79  (0.36) 0.49  (0.27)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection MultiHance, Magnevist
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Mean difference of Multihance minus Magnevist for change from baseline
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.30
Confidence Interval 95%
0.22 to 0.38
Parameter Dispersion
Type: Standard Deviation
Value: 0.20
Estimation Comments [Not Specified]
6.Secondary Outcome
Title Lesion-to-brain Ratio (LBR) for Each Lesion - Reader 3
Hide Description Change from predose to postdose in lesion-to-brain ratio computed. Comparison of the differences in change were analyzed.
Time Frame Predose and immediately postdose
Hide Outcome Measure Data
Hide Analysis Population Description
Include all ITT population. The number of units analyzed are the total number of lesions assessed by the reader from the total number of participants. Lesion-level analysis.
Arm/Group Title MultiHance Magnevist
Hide Arm/Group Description:
0.1 mmol/kg injection
0.1 mmol/kg injection
Overall Number of Participants Analyzed 41 41
Overall Number of Units Analyzed
Type of Units Analyzed: Lesions
26 26
Mean (Standard Deviation)
Unit of Measure: [ratio]
Predose 0.86  (0.17) 0.91  (0.17)
Postdose 1.67  (0.36) 1.46  (0.26)
Change from Baseline 0.81  (0.41) 0.55  (0.31)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection MultiHance, Magnevist
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Mean difference of Multihance minus Magnevist for change from baseline
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.25
Confidence Interval 95%
0.18 to 0.33
Parameter Dispersion
Type: Standard Deviation
Value: 0.19
Estimation Comments [Not Specified]
7.Secondary Outcome
Title Contrast-to-noise Ratio (CNR) for Each Lesion - Reader 1
Hide Description Change from predose to postdose in contrast-to-noise ratio computed. Comparison of the differences in change were analyzed.
Time Frame Predose and immediately postdose
Hide Outcome Measure Data
Hide Analysis Population Description
Include all ITT population. The number of units analyzed are the total number of lesions assessed by the reader from the total number of participants. Lesion-level analysis.
Arm/Group Title MultiHance Magnevist
Hide Arm/Group Description:
0.1 mmol/kg injection
0.1 mmol/kg injection
Overall Number of Participants Analyzed 41 41
Overall Number of Units Analyzed
Type of Units Analyzed: Lesions
27 27
Mean (Standard Deviation)
Unit of Measure: [ratio]
Predose -18.81  (19.22) -11.70  (20.85)
Postdose 60.76  (66.88) 26.87  (28.36)
Change from Baseline 79.56  (71.57) 38.57  (33.70)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection MultiHance, Magnevist
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0062
Comments Mean difference of Multihance minus Magnevist for change from baseline
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 40.99
Confidence Interval 95%
20.72 to 61.26
Parameter Dispersion
Type: Standard Deviation
Value: 59.78
Estimation Comments [Not Specified]
8.Secondary Outcome
Title Contrast-to-noise Ratio (CNR) for Each Lesion - Reader 2
Hide Description Change from predose to postdose in contrast-to-noise ratio computed. Comparison of the differences in change were analyzed.
Time Frame Predose and immediately postdose
Hide Outcome Measure Data
Hide Analysis Population Description
Include all ITT population. The number of units analyzed are the total number of lesions assessed by the reader from the total number of participants. Lesion-level analysis.
Arm/Group Title MultiHance Magnevist
Hide Arm/Group Description:
0.1 mmol/kg injection
0.1 mmol/kg injection
Overall Number of Participants Analyzed 41 41
Overall Number of Units Analyzed
Type of Units Analyzed: Lesions
25 25
Mean (Standard Deviation)
Unit of Measure: [ratio]
Predose -18.30  (19.11) -14.38  (18.92)
Postdose 65.96  (54.75) 38.94  (40.41)
Change from Baseline 84.26  (63.43) 53.31  (52.46)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection MultiHance, Magnevist
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0027
Comments Mean difference of Multihance minus Magnevist for change from baseline
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 30.95
Confidence Interval 95%
16.57 to 45.33
Parameter Dispersion
Type: Standard Deviation
Value: 48.64
Estimation Comments [Not Specified]
9.Secondary Outcome
Title Contrast-to-noise Ratio (CNR) for Each Lesion - Reader 3
Hide Description Change from predose to postdose in contrast-to-noise ratio computed. Comparison of the differences in change were analyzed.
Time Frame Predose and immediately postdose
Hide Outcome Measure Data
Hide Analysis Population Description
Include all ITT population. The number of units analyzed are the total number of lesions assessed by the reader from the total number of participants. Lesion-level analysis.
Arm/Group Title MultiHance Magnevist
Hide Arm/Group Description:
0.1 mmol/kg injection
0.1 mmol/kg injection
Overall Number of Participants Analyzed 41 41
Overall Number of Units Analyzed
Type of Units Analyzed: Lesions
26 26
Mean (Standard Deviation)
Unit of Measure: [ratio]
Predose -11.75  (17.70) -6.47  (17.20)
Postdose 62.10  (42.92) 42.34  (33.49)
Change from Baseline 73.84  (47.60) 48.81  (37.51)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection MultiHance, Magnevist
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.02
Comments Mean difference of Multihance minus Magnevist for change from baseline
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Median Difference (Final Values)
Estimated Value 25.04
Confidence Interval 95%
12.41 to 37.67
Parameter Dispersion
Type: Standard Deviation
Value: 37.37
Estimation Comments [Not Specified]
10.Secondary Outcome
Title Percentage of Contrast Enhancement of the Lesion - Reader 1
Hide Description Quantitative parameter derived from signal intensity (SI) measurements. LCE ([SI of lesion (postdose)-SI of lesion (predose)]/Standard SI of lesion (predose)]
Time Frame Postdose
Hide Outcome Measure Data
Hide Analysis Population Description
Include all ITT population. The number of units analyzed are the total number of lesions assessed by the reader from the total number of participants. Lesion-level analysis.
Arm/Group Title MultiHance Magnevist
Hide Arm/Group Description:
0.1 mmol/kg injection
0.1 mmol/kg injection
Overall Number of Participants Analyzed 41 41
Overall Number of Units Analyzed
Type of Units Analyzed: Lesions
27 27
Mean (Standard Deviation)
Unit of Measure: [percent]
100.15  (74.92) 67.38  (52.18)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection MultiHance, Magnevist
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0019
Comments Mean difference of Multihance minus Magnevist
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 32.77
Confidence Interval 95%
14.28 to 51.25
Parameter Dispersion
Type: Standard Deviation
Value: 48.51
Estimation Comments [Not Specified]
11.Secondary Outcome
Title Percentage of Contrast Enhancement of the Lesion - Reader 2
Hide Description Quantitative parameter derived from signal intensity (SI) measurements. LCE ([SI of lesion (postdose)-SI of lesion (predose)]/Standard SI of lesion (predose)]
Time Frame Postdose
Hide Outcome Measure Data
Hide Analysis Population Description
Include all ITT population. The number of units analyzed are the total number of lesions assessed by the reader from the total number of participants. Lesion-level analysis.
Arm/Group Title MultiHance Magnevist
Hide Arm/Group Description:
0.1 mmol/kg injection
0.1 mmol/kg injection
Overall Number of Participants Analyzed 41 41
Overall Number of Units Analyzed
Type of Units Analyzed: Lesions
25 25
Mean (Standard Deviation)
Unit of Measure: [percent]
106.42  (84.97) 72.81  (65.70)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection MultiHance, Magnevist
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0008
Comments Mean difference of Multihance minus Magnevist
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 33.61
Confidence Interval 95%
16.75 to 50.47
Parameter Dispersion
Type: Standard Deviation
Value: 43.16
Estimation Comments [Not Specified]
12.Secondary Outcome
Title Percentage of Contrast Enhancement of the Lesion - Reader 3
Hide Description Quantitative parameter derived from signal intensity (SI) measurements. LCE ([SI of lesion (postdose)-SI of lesion (predose)]/Standard SI of lesion (predose)]
Time Frame Postdose
Hide Outcome Measure Data
Hide Analysis Population Description
Include all ITT population. The number of units analyzed are the total number of lesions assessed by the reader from the total number of participants. Lesion-level analysis.
Arm/Group Title MultiHance Magnevist
Hide Arm/Group Description:
0.1 mmol/kg injection
0.1 mmol/kg injection
Overall Number of Participants Analyzed 41 41
Overall Number of Units Analyzed
Type of Units Analyzed: Lesions
26 26
Mean (Standard Deviation)
Unit of Measure: [percent]
101.85  (96.89) 68.13  (60.91)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection MultiHance, Magnevist
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0026
Comments Mean difference of Multihance minus Magnevist
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 33.72
Confidence Interval 95%
14.63 to 52.81
Parameter Dispersion
Type: Standard Deviation
Value: 48.50
Estimation Comments [Not Specified]
Time Frame Adverse events were monitored from time of signed informed consent, & within 24 hrs prior to administration of contrast agent (1st exam) until 24 hrs after administration of contrast agent. Repeated for 2nd exam.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title MultiHance Magnevist
Hide Arm/Group Description Adverse events experienced by patients occurred relative to the administration of MultiHance. Adverse events experienced by patients occurred relative to the administration of Magnevist.
All-Cause Mortality
MultiHance Magnevist
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
MultiHance Magnevist
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/43 (0.00%)      0/44 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 2%
MultiHance Magnevist
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   4/43 (9.30%)      1/44 (2.27%)    
Ear and labyrinth disorders     
Ear discomfort * 1  1/43 (2.33%)  1 0/44 (0.00%)  0
Gastrointestinal disorders     
Nausea * 1  2/43 (4.65%)  2 0/44 (0.00%)  0
Vomiting * 1  1/43 (2.33%)  1 0/44 (0.00%)  0
General disorders     
Fatigue * 1  0/43 (0.00%)  0 1/44 (2.27%)  1
Nervous system disorders     
Headache * 1  1/43 (2.33%)  1 0/44 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (9.1)
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.
The results of the study may be presented during scientific symposia or published in a scientific journal only after review by Bracco in accordance with the guidelines set forth in the applicable publication or financial agreement.
Results Point of Contact
Name/Title: Gianpaolo Pirovano
Organization: Executive Director, Head Corporate Medical Development
Phone: 609-514-2226
Responsible Party: Bracco Diagnostics, Inc
ClinicalTrials.gov Identifier: NCT00395863     History of Changes
Other Study ID Numbers: MH 126
First Submitted: September 12, 2006
First Posted: November 6, 2006
Results First Submitted: March 30, 2009
Results First Posted: July 31, 2009
Last Update Posted: April 14, 2015