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:

Bayer

ClinicalTrials.gov Identifier:

NCT00709852

First received: July 1, 2008

Last updated: February 6, 2013

Last verified: February 2013

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

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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

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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 ]

Hide Outcome Measure 25

Measure Type	Secondary
Measure Title	Scores for Two Visualization Parameters (Border Delineation and Internal Morphology) for Combined Unenhanced/Gadoteridol-enhanced MRI Compared to Unenhanced MRI by Clinical Investigator
Measure Description	The clinical investigators evaluated the images from the unenhanced MRI and the images from the combined unenhanced and gadoteridol-enhanced MRIs. Border delineation was scored on a 4-point scale where 1 = no or unclear delineation and 4 = excellent delineation. Internal morphology was scored on a 3-point scale where 1 = poorly visible and 3 = sufficiently visible.
Time Frame	Up to 2 hours after injection of gadoteridol
Safety Issue	No

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.
All participants in the FAS with assessments for this outcome measure.

Reporting Groups

	Description
Unenhanced	Participants had diagnostic imaging before receiving any contrast agent
Combined Unenhanced/Gadoteridol-enhanced	Participants received a single dose of gadoteridol at the approved dose, 0.1 mmol/kg bw, via i.v.

Measured Values

	Unenhanced	Combined Unenhanced/Gadoteridol-enhanced
Number of Participants Analyzed [units: participants]	329	329
Scores for Two Visualization Parameters (Border Delineation and Internal Morphology) for Combined Unenhanced/Gadoteridol-enhanced MRI Compared to Unenhanced MRI by Clinical Investigator [units: scores on a scale] Mean ± Standard Deviation
border delineation	2.17 ± 0.61	2.88 ± 0.60
internal morphology	1.78 ± 0.55	2.36 ± 0.49

Statistical Analysis 1 for Scores for Two Visualization Parameters (Border Delineation and Internal Morphology) for Combined Unenhanced/Gadoteridol-enhanced MRI Compared to Unenhanced MRI by Clinical Investigator

Groups ^[1]	All groups
Method ^[2]	paired t test
P Value ^[3]	< 0.0001
Mean Difference (Final Values) ^[4]	0.71
Standard Deviation	± 0.76

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	for border delineation
[4]	Other relevant estimation information:
	No text entered.

Statistical Analysis 2 for Scores for Two Visualization Parameters (Border Delineation and Internal Morphology) for Combined Unenhanced/Gadoteridol-enhanced MRI Compared to Unenhanced MRI by Clinical Investigator

Groups ^[1]	All groups
Method ^[2]	paired t test
P Value ^[3]	< 0.0001
Mean Difference (Final Values) ^[4]	0.58
Standard Deviation	± 0.63

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	for internal morphology
[4]	Other relevant estimation information:
	No text entered.

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

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Other Adverse Events

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More Information

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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:

	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.
	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.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: The sponsor is interested in the publication of the results of every study it performs. All relevant aspects regarding publication will be part of the contract between the sponsor and the investigator/institution. The sponsor has committed to the global industry position on disclosure of information about clinical trials. The information regarding the study protocol is made publicly available on the internet at www.clinicaltrials.gov.

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.

Results Point of Contact:

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

No publications provided

Responsible Party:	Therapeutic Area Head, Bayer HealthCare Pharmaceuticals Inc.
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:	February 6, 2013
Health Authority:	United States: Food and Drug Administration

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