Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials
Text Size

Safety and Efficacy of Gadobutrol 1.0 Molar (Gadavist) in Patients for Central Nervous System (CNS) Imaging

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT00709852
First received: July 1, 2008
Last updated: December 8, 2014
Last verified: December 2014
History of Changes
Results First Received: August 19, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Crossover Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Diagnostic
Conditions: Diagnostic Imaging
Central Nervous System Diseases
Interventions: Drug: Gadobutrol (Gadavist, Gadovist, BAY86-4875)
Drug: Gadoteridol (ProHance)

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
The date of the first participant's first visit was 11 JUN 2008. The date of the last participant's last visit was 03 APR 2009.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
A total of 419 participants (part.) were screened; 17 prematurely discontinued prior to receiving any study drug. A total of 402 part. received study drug; 228 in gadobutrol : gadoteridol treatment sequence, 174 in gadoteridol : gadobutrol treatment sequence. Safety analysis set=402; gadobutrol=399, gadoteridol=393. Full analysis set (FAS)=336.

Reporting Groups
  Description
Gadobutrol (Gadavist, BAY86-4875) : Gadoteridol (ProHance) Participants received a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous) in Period 1 and a single dose of gadoteridol at the approved dose, 0.1 mmol/kg bw, via i.v. in Period 2.
Gadoteridol (ProHance) : Gadobutrol (Gadavist, BAY86-4875) Participants received a single dose of gadoteridol at the approved dose, 0.1 mmol/kg bw, via i.v. in Period 1 and a single dose of gadobutrol 0.1 mmol/kg bw via i.v. in Period 2.

Participant Flow for 2 periods

 Period 1:   Period 1
    Gadobutrol (Gadavist, BAY86-4875) : Gadoteridol (ProHance)     Gadoteridol (ProHance) : Gadobutrol (Gadavist, BAY86-4875)  
STARTED     228     174  
COMPLETED     220     171  
NOT COMPLETED     8     3  
Adverse Event                 2                 0  
Withdrawal by Subject                 4                 2  
Protocol Violation                 1                 0  
Defective scanner                 0                 1  
Lost to Follow-up                 1                 0  

Period 2:   Period 2
    Gadobutrol (Gadavist, BAY86-4875) : Gadoteridol (ProHance)     Gadoteridol (ProHance) : Gadobutrol (Gadavist, BAY86-4875)  
STARTED     220     171  
COMPLETED     211     169  
NOT COMPLETED     9     2  
Protocol Violation                 4                 1  
Adverse Event                 1                 1  
Lost to Follow-up                 1                 0  
No 72-hour follow-up                 3                 0  



  Baseline Characteristics
  Hide Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Entire Study Population Includes participants who received either treatment

Baseline Measures
    Entire Study Population  
Number of Participants  
[units: participants]
 		  402  
Age, Customized  
[units: participants]
 		 
< 45 years     144  
45-64 years     164  
≥ 65 years     94  
Gender  
[units: participants]
 		 
Female     227  
Male     175  
Race/Ethnicity, Customized  
[units: participants]
 		 
Caucasian     235  
Black     23  
Hispanic     31  
Asian     112  
Other     1  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Scores for Three Visualization Parameters (Contrast Enhancement, Border Delineation and Internal Morphology) for Combined Unenhanced/Gadobutrol-enhanced Magnetic Resonance Imaging (MRI) Compared to Unenhanced MRI by Blinded Reader 1 (BR1)   [ Time Frame: Up to 2 hours after injection of gadobutrol ]
  Show Outcome Measure 1

2.  Primary:   Scores for Three Visualization Parameters (Contrast Enhancement, Border Delineation and Internal Morphology) for Combined Unenhanced/Gadobutrol-enhanced Magnetic Resonance Imaging (MRI) Compared to Unenhanced MRI by Blinded Reader 2 (BR2)   [ Time Frame: Up to 2 hours after injection of gadobutrol ]
  Show Outcome Measure 2

3.  Primary:   Scores for Three Visualization Parameters (Contrast Enhancement, Border Delineation and Internal Morphology) for Combined Unenhanced/Gadobutrol-enhanced Magnetic Resonance Imaging (MRI) Compared to Unenhanced MRI by Blinded Reader 3 (BR3)   [ Time Frame: Up to 2 hours after injection of gadobutrol ]
  Show Outcome Measure 3

4.  Primary:   Scores for Three Visualization Parameters (Contrast Enhancement, Border Delineation and Internal Morphology) for Combined Unenhanced/Gadobutrol-enhanced Magnetic Resonance Imaging (MRI) Compared to Unenhanced MRI by Average Reader (AR)   [ Time Frame: Up to 2 hours after injection of gadobutrol ]
  Show Outcome Measure 4

5.  Primary:   Number of Lesions for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Blinded Readers   [ Time Frame: Up to 2 hours after injection of gadobutrol ]
  Show Outcome Measure 5

6.  Primary:   Scores for Three Visualization Parameters (Contrast Enhancement, Border Delineation and Internal Morphology) for Normal Structures for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Blinded Reader 1 (BR1)   [ Time Frame: Up to 2 hours after injection of gadobutrol ]
  Show Outcome Measure 6

7.  Primary:   Scores for Three Visualization Parameters (Contrast Enhancement, Border Delineation and Internal Morphology) for Normal Structures for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Blinded Reader 2 (BR2)   [ Time Frame: Up to 2 hours after injection of gadobutrol ]
  Show Outcome Measure 7

8.  Primary:   Scores for Three Visualization Parameters (Contrast Enhancement, Border Delineation and Internal Morphology) for Normal Structures for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Blinded Reader 3 (BR3)   [ Time Frame: Up to 2 hours after injection of gadobutrol ]
  Show Outcome Measure 8

9.  Primary:   Scores for Three Visualization Parameters (Contrast Enhancement, Border Delineation and Internal Morphology) for Normal Structures for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Average Reader (AR)   [ Time Frame: Up to 2 hours after injection of gadobutrol ]
  Show Outcome Measure 9

10.  Primary:   Scores for Three Visualization Parameters (Contrast Enhancement, Border Delineation and Internal Morphology) for Lesions for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Blinded Reader 1 (BR1)   [ Time Frame: Up to 2 hours after injection of gadobutrol ]
  Show Outcome Measure 10

11.  Primary:   Scores for Three Visualization Parameters (Contrast Enhancement, Border Delineation and Internal Morphology) for Lesions for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Blinded Reader 2 (BR2)   [ Time Frame: Up to 2 hours after injection of gadobutrol ]
  Show Outcome Measure 11

12.  Primary:   Scores for Three Visualization Parameters (Contrast Enhancement, Border Delineation and Internal Morphology) for Lesions for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Blinded Reader 3 (BR3)   [ Time Frame: Up to 2 hours after injection of gadobutrol ]
  Show Outcome Measure 12

13.  Primary:   Scores for Three Visualization Parameters (Contrast Enhancement, Border Delineation and Internal Morphology) for Lesions for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Average Reader (AR)   [ Time Frame: Up to 2 hours after injection of gadobutrol ]
  Show Outcome Measure 13

14.  Secondary:   Scores for Three Visualization Parameters (Contrast Enhancement, Border Delineation and Internal Morphology) for Combined Unenhanced/Gadoteridol-enhanced MRI Compared to Unenhanced MRI by Average Reader   [ Time Frame: Up to 2 hours after injection of gadoteridol ]
  Show Outcome Measure 14

15.  Secondary:   Number of Lesions for Combined Unenhanced/Gadoteridol-enhanced MRI Compared to Unenhanced MRI by Average Reader   [ Time Frame: Up to 2 hours after injection of gadoteridol ]
  Show Outcome Measure 15

16.  Secondary:   Scores for Three Visualization Parameters (Contrast Enhancement, Border Delineation and Internal Morphology) for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Combined Unenhanced/Gadoteridol-enhanced MRI by Average Reader   [ Time Frame: Up to 2 hours after injection of gadobutrol or gadoteridol ]
  Show Outcome Measure 16

17.  Secondary:   Number of Lesions for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Combined Unenhanced/Gadoteridol-enhanced MRI by Average Reader   [ Time Frame: Up to 2 hours after injection of gadobutrol or gadoteridol ]
  Show Outcome Measure 17

18.  Secondary:   Percentage of Participants With More Lesions Detected for Combined Unenhanced/Gadobutrol-enhanced MRI or for Unenhanced MRI by Blinded Readers   [ Time Frame: Up to 2 hours after injection of gadobutrol ]
  Show Outcome Measure 18

19.  Secondary:   Percentage of Participants With More Lesions Detected for Combined Unenhanced/Gadoteridol-enhanced MRI or for Unenhanced MRI by Average Reader   [ Time Frame: Up to 2 hours after injection of gadoteridol ]
  Show Outcome Measure 19

20.  Secondary:   Percentage of Participants With More Lesions Detected for Combined Unenhanced/Gadobutrol-enhanced MRI or for Combined Unenhanced/Gadoteridol-enhanced MRI by Average Reader   [ Time Frame: Up to 2 hours after injection of gadobutrol or gadoteridol ]
  Show Outcome Measure 20

21.  Secondary:   Scores for Two Visualization Parameters (Border Delineation and Internal Morphology) for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Clinical Investigator   [ Time Frame: Up to 2 hours after injection of gadobutrol ]
  Show Outcome Measure 21

22.  Secondary:   Number of Lesions for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Clinical Investigator   [ Time Frame: Up to 2 hours after injection of gadobutrol ]
  Show Outcome Measure 22

23.  Secondary:   Scores for Two Visualization Parameters (Border Delineation and Internal Morphology) for Normal Structures for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Clinical Investigator   [ Time Frame: Up to 2 hours after injection of gadobutrol ]
  Show Outcome Measure 23

24.  Secondary:   Scores for Two Visualization Parameters (Border Delineation and Internal Morphology) for Lesions for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Clinical Investigator   [ Time Frame: Up to 2 hours after injection of gadobutrol ]
  Show Outcome Measure 24

25.  Secondary:   Scores for Two Visualization Parameters (Border Delineation and Internal Morphology) for Combined Unenhanced/Gadoteridol-enhanced MRI Compared to Unenhanced MRI by Clinical Investigator   [ Time Frame: Up to 2 hours after injection of gadoteridol ]
  Show Outcome Measure 25

26.  Secondary:   Number of Lesions for Combined Unenhanced/Gadoteridol-enhanced MRI Compared to Unenhanced MRI by Clinical Investigator   [ Time Frame: Up to 2 hours after injection of gadoteridol ]
  Show Outcome Measure 26

27.  Secondary:   Scores for Two Visualization Parameters (Border Delineation and Internal Morphology) for Normal Structures for Combined Unenhanced/Gadoteridol-enhanced MRI Compared to Unenhanced MRI by Clinical Investigator   [ Time Frame: Up to 2 hours after injection of gadoteridol ]
  Show Outcome Measure 27

28.  Secondary:   Scores for Two Visualization Parameters (Border Delineation and Internal Morphology) for Lesions for Combined Unenhanced/Gadoteridol-enhanced MRI Compared to Unenhanced MRI by Clinical Investigator   [ Time Frame: Up to 2 hours after injection of gadoteridol ]
  Show Outcome Measure 28

29.  Secondary:   Scores for Three Visualization Parameters (Contrast Enhancement, Border Delineation and Internal Morphology) for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Combined Unenhanced/Gadoteridol-enhanced MRI by Clinical Investigator   [ Time Frame: Up to 2 hours after injection of gadobutrol or gadoteridol ]
  Show Outcome Measure 29

30.  Secondary:   Number of Lesions for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Combined Unenhanced/Gadoteridol-enhanced MRI by Clinical Investigator   [ Time Frame: Up to 2 hours after injection of gadobutrol or gadoteridol ]
  Show Outcome Measure 30

31.  Secondary:   Scores for Contrast Enhancement, Border Delineation and Internal Morphology for Normal Structures for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Combined Unenhanced/Gadoteridol-enhanced MRI by Clinical Investigator   [ Time Frame: Up to 2 hours after injection of gadobutrol or gadoteridol ]
  Show Outcome Measure 31

32.  Secondary:   Scores for Contrast Enhancement, Border Delineation and Internal Morphology for Lesions for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Combined Unenhanced/Gadoteridol-enhanced MRI by Clinical Investigator   [ Time Frame: Up to 2 hours after injection of gadobutrol or gadoteridol ]
  Show Outcome Measure 32

33.  Secondary:   Percentage (Per.) of the Exact Diagnostic Matches (Accuracy of Diagnosis) for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Majority Reader   [ Time Frame: Up to 2 hours after injection of gadobutrol ]
  Show Outcome Measure 33

34.  Secondary:   Percentage (Per.) of the Exact Diagnostic Matches (Accuracy of Diagnosis) for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Clinical Investigator   [ Time Frame: Up to 2 hours after injection of gadobutrol ]
  Show Outcome Measure 34

35.  Secondary:   Percentage (Per.) of the Exact Diagnostic Matches (Accuracy of Diagnosis) for Combined Unenhanced/Gadoteridol-enhanced MRI Compared to Unenhanced MRI by Majority Reader   [ Time Frame: Up to 2 hours after injection of gadoteridol ]
  Show Outcome Measure 35

36.  Secondary:   Percentage (Per.) of the Exact Diagnostic Matches (Accuracy of Diagnosis) for Combined Unenhanced/Gadoteridol-enhanced MRI Compared to Unenhanced MRI by Clinical Investigator   [ Time Frame: Up to 2 hours after injection of gadoteridol ]
  Show Outcome Measure 36

37.  Secondary:   Percentage (Per.) of the Exact Diagnostic Matches (Accuracy of Diagnosis) for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Combined Unenhanced/Gadoteridol-enhanced MRI by Majority Reader   [ Time Frame: Up to 2 hours after injection of gadobutrol or gadoteridol ]
  Show Outcome Measure 37

38.  Secondary:   Percentage (Per.) of the Exact Diagnostic Matches (Accuracy of Diagnosis) for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Combined Unenhanced/Gadoteridol-enhanced MRI by Clinical Investigator   [ Time Frame: Up to 2 hours after injection of gadobutrol or gadoteridol ]
  Show Outcome Measure 38

39.  Secondary:   Accuracy of Detection of Normal/Abnormal Brain Tissue for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Majority Reader Using T1-weighted (T1w) Images   [ Time Frame: Up to 2 hours after injection of gadobutrol ]
  Show Outcome Measure 39

40.  Secondary:   Sensitivity of Detection of Normal/Abnormal Brain Tissue for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Majority Reader Using T1-weighted (T1w) Images   [ Time Frame: Up to 2 hours after injection of gadobutrol ]
  Show Outcome Measure 40

41.  Secondary:   Specificity of Detection of Normal/Abnormal Brain Tissue for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Majority Reader Using T1-weighted (T1w) Images   [ Time Frame: Up to 2 hours after injection of gadobutrol ]
  Show Outcome Measure 41

42.  Secondary:   Accuracy of Detection of Normal/Abnormal Brain Tissue for Combined Unenhanced/Gadoteridol-enhanced MRI Compared to Unenhanced MRI by Majority Reader Using T1-weighted (T1w) Images   [ Time Frame: Up to 2 hours after injection of gadoteridol ]
  Show Outcome Measure 42

43.  Secondary:   Sensitivity of Detection of Normal/Abnormal Brain Tissue for Combined Unenhanced/Gadoteridol-enhanced MRI Compared to Unenhanced MRI by Majority Reader Using T1-weighted (T1w) Images   [ Time Frame: Up to 2 hours after injection of gadoteridol ]
  Show Outcome Measure 43

44.  Secondary:   Specificity of Detection of Normal/Abnormal Brain Tissue for Combined Unenhanced/Gadoteridol-enhanced MRI Compared to Unenhanced MRI by Majority Reader Using T1-weighted (T1w) Images   [ Time Frame: Up to 2 hours after injection of gadoteridol ]
  Show Outcome Measure 44

45.  Secondary:   Accuracy of Detection of Normal/Abnormal Brain Tissue for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Combined Unenhanced/Gadoteridol-enhanced MRI by Majority Reader Using T1-weighted (T1w) Images   [ Time Frame: Up to 2 hours after injection of gadobutrol or gadoteridol ]
  Show Outcome Measure 45

46.  Secondary:   Sensitivity of Detection of Normal/Abnormal Brain Tissue for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Combined Unenhanced/Gadoteridol-enhanced MRI by Majority Reader Using T1-weighted (T1w) Images   [ Time Frame: Up to 2 hours after injection of gadobutrol or gadoteridol ]
  Show Outcome Measure 46

47.  Secondary:   Specificity of Detection of Normal/Abnormal Brain Tissue for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Combined Unenhanced/Gadoteridol-enhanced MRI by Majority Reader Using T1-weighted (T1w) Images   [ Time Frame: Up to 2 hours after injection of gadobutrol or gadoteridol ]
  Show Outcome Measure 47

48.  Secondary:   Accuracy of Detection of Malignant Lesions (ML) for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Majority Reader   [ Time Frame: Up to 2 hours after injection of gadobutrol ]
  Show Outcome Measure 48

49.  Secondary:   Sensitivity of Detection of Malignant Lesions (ML) for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Majority Reader   [ Time Frame: Up to 2 hours after injection of gadobutrol ]
  Show Outcome Measure 49

50.  Secondary:   Specificity of Detection of Malignant Lesions (ML) for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Majority Reader   [ Time Frame: Up to 2 hours after injection of gadobutrol ]
  Show Outcome Measure 50

51.  Secondary:   Accuracy of Detection of Malignant Lesions (ML) for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Clinical Investigator   [ Time Frame: Up to 2 hours after injection of gadobutrol ]
  Show Outcome Measure 51

52.  Secondary:   Sensitivity of Detection of Malignant Lesions (ML) for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Clinical Investigator   [ Time Frame: Up to 2 hours after injection of gadobutrol ]
  Show Outcome Measure 52

53.  Secondary:   Specificity of Detection of Malignant Lesions (ML) for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Clinical Investigator   [ Time Frame: Up to 2 hours after injection of gadobutrol ]
  Show Outcome Measure 53

54.  Secondary:   Accuracy of Detection of Malignant Lesions (ML) for Combined Unenhanced/Gadoteridol-enhanced MRI Compared to Unenhanced MRI by Majority Reader   [ Time Frame: Up to 2 hours after injection of gadoteridol ]
  Show Outcome Measure 54

55.  Secondary:   Sensitivity of Detection of Malignant Lesions (ML) for Combined Unenhanced/Gadoteridol-enhanced MRI Compared to Unenhanced MRI by Majority Reader   [ Time Frame: Up to 2 hours after injection of gadoteridol ]
  Show Outcome Measure 55

56.  Secondary:   Specificity of Detection of Malignant Lesions (ML) for Combined Unenhanced/Gadoteridol-enhanced MRI Compared to Unenhanced MRI by Majority Reader   [ Time Frame: Up to 2 hours after injection of gadoteridol ]
  Show Outcome Measure 56

57.  Secondary:   Accuracy of Detection of Malignant Lesions (ML) for Combined Unenhanced/Gadoteridol-enhanced MRI Compared to Unenhanced MRI by Clinical Investigator   [ Time Frame: Up to 2 hours after injection of gadoteridol ]
  Show Outcome Measure 57

58.  Secondary:   Sensitivity of Detection of Malignant Lesions (ML) for Combined Unenhanced/Gadoteridol-enhanced MRI Compared to Unenhanced MRI by Clinical Investigator   [ Time Frame: Up to 2 hours after injection of gadoteridol ]
  Show Outcome Measure 58

59.  Secondary:   Specificity of Detection of Malignant Lesions (ML) for Combined Unenhanced/Gadoteridol-enhanced MRI Compared to Unenhanced MRI by Clinical Investigator   [ Time Frame: Up to 2 hours after injection of gadoteridol ]
  Show Outcome Measure 59

60.  Secondary:   Accuracy of Detection of Malignant Lesions (ML) for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Combined Unenhanced/Gadoteridol-enhanced MRI by Majority Reader   [ Time Frame: Up to 2 hours after injection of gadobutrol or gadoteridol ]
  Show Outcome Measure 60

61.  Secondary:   Sensitivity of Detection of Malignant Lesions (ML) for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Combined Unenhanced/Gadoteridol-enhanced MRI by Majority Reader   [ Time Frame: Up to 2 hours after injection of gadobutrol or gadoteridol ]
  Show Outcome Measure 61

62.  Secondary:   Specificity of Detection of Malignant Lesions (ML) for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Combined Unenhanced/Gadoteridol-enhanced MRI by Majority Reader   [ Time Frame: Up to 2 hours after injection of gadobutrol or gadoteridol ]
  Show Outcome Measure 62

63.  Secondary:   Accuracy of Detection of Malignant Lesions (ML) for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Combined Unenhanced/Gadoteridol-enhanced MRI by Clinical Investigator   [ Time Frame: Up to 2 hours after injection of gadobutrol or gadoteridol ]
  Show Outcome Measure 63

64.  Secondary:   Sensitivity of Detection of Malignant Lesions (ML) for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Combined Unenhanced/Gadoteridol-enhanced MRI by Clinical Investigator   [ Time Frame: Up to 2 hours after injection of gadobutrol or gadoteridol ]
  Show Outcome Measure 64

65.  Secondary:   Specificity of Detection of Malignant Lesions (ML) for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Combined Unenhanced/Gadoteridol-enhanced MRI by Clinical Investigator   [ Time Frame: Up to 2 hours after injection of gadobutrol or gadoteridol ]
  Show Outcome Measure 65

66.  Secondary:   Diagnostic Confidence for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Average Reader   [ Time Frame: Up to 2 hours after injection of gadobutrol ]
  Show Outcome Measure 66

67.  Secondary:   Diagnostic Confidence for Combined Unenhanced/Gadoteridol-enhanced MRI Compared to Unenhanced MRI by Average Reader   [ Time Frame: Up to 2 hours after injection of gadoteridol ]
  Show Outcome Measure 67

68.  Secondary:   Diagnostic Confidence for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Combined Unenhanced/Gadoteridol-enhanced MRI by Average Reader   [ Time Frame: Up to 2 hours after injection of gadobutrol or gadoteridol ]
  Show Outcome Measure 68

69.  Secondary:   Diagnostic Confidence for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Clinical Investigator   [ Time Frame: Up to 2 hours after injection of gadobutrol ]
  Show Outcome Measure 69

70.  Secondary:   Diagnostic Confidence for Combined Unenhanced/Gadoteridol-enhanced MRI Compared to Unenhanced MRI by Clinical Investigator   [ Time Frame: Up to 2 hours after injection of gadoteridol ]
  Show Outcome Measure 70

71.  Secondary:   Diagnostic Confidence for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Combined Unenhanced/Gadoteridol-enhanced MRI by Clinical Investigator   [ Time Frame: Up to 2 hours after injection of gadobutrol or gadoteridol ]
  Show Outcome Measure 71

72.  Secondary:   Comparison of Image Quality Between Gadobutrol and Gadoteridol by Blinded Readers   [ Time Frame: Up to 2 hours after injection of gadobutrol or gadoteridol ]
  Show Outcome Measure 72

73.  Secondary:   Percentage of Participants for Which Blinded Readers Said Image Quality Was Higher   [ Time Frame: Up to 2 hours after injection of gadobutrol or gadoteridol ]
  Show Outcome Measure 73

74.  Secondary:   Assessment of the Number of Contrast-enhanced Lesions for Gadobutrol and Gadoteridol by Blinded Readers   [ Time Frame: Up to 2 hours after injection of gadobutrol or gadoteridol ]
  Show Outcome Measure 74

75.  Secondary:   Percentage of Lesion Enhancement From Unenhanced to Combined Unenhanced/Enhanced for Gadobutrol and Gadoteridol by Blinded Readers   [ Time Frame: Up to 2 hours after injection of gadobutrol or gadoteridol ]
  Show Outcome Measure 75


  Serious Adverse Events
  Show Serious Adverse Events


  Other Adverse Events
  Show Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
  Hide More Information

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 agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Therapeutic Area Head
Organization: BAYER
e-mail: clinical-trials-contact@bayerhealthcare.com


No publications provided


Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT00709852     History of Changes
Other Study ID Numbers: 91681, 2007-004746-33, 310123
Study First Received: July 1, 2008
Results First Received: August 19, 2011
Last Updated: December 8, 2014
Health Authority: United States: Food and Drug Administration