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:

NCT00623467

First received: February 18, 2008

Last updated: February 7, 2013

Last verified: February 2013

History of Changes

Results First Received: June 20, 2011

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Single Group Assignment; Masking: Open Label; Primary Purpose: Diagnostic
Condition:	Central Nervous System Diseases
Intervention:	Drug: Gadobutrol (Gadavist, Gadovist, BAY86-4875)

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 17 DEC 2007. The date of the last participant's last visit was 12 DEC 2008.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
A total of 347 participants were screened for inclusion into the study; 4 participants failed screening because they did not meet the inclusion criteria. Therefore, 343 participants were enrolled into the study and received study drug.

Reporting Groups

	Description
Gadobutrol (Gadavist, BAY86-4875)	Participants were administered a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous) bolus administration using a power injector via a peripheral vein (an antecubital vein was preferred). Gadobutrol was injected at a rate of 2 mL/second followed by a 20-mL 0.9% saline flush at the same rate.

Participant Flow: Overall Study

	Gadobutrol (Gadavist, BAY86-4875)
STARTED	343
COMPLETED	336
NOT COMPLETED	7
Lost to Follow-up	1
Protocol Violation	4
Withdrawal by Subject	2

Baseline Characteristics

Hide Baseline Characteristics

Reporting Groups

	Description
Gadobutrol (Gadavist, BAY86-4875)	Participants were administered a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous) bolus administration using a power injector via a peripheral vein (an antecubital vein was preferred). Gadobutrol was injected at a rate of 2 mL/second followed by a 20-mL 0.9% saline flush at the same rate.

Baseline Measures

	Gadobutrol (Gadavist, BAY86-4875)
Number of Participants [units: participants]	343
Age, Customized [units: participants]
< 45 years	149
45 - 64 years	145
≥ 65 years	49
Gender [units: participants]
Female	197
Male	146
Race/Ethnicity, Customized [units: participants]
Caucasian	68
Black	9
Hispanic	87
Asian	161
Other	18

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. Secondary:

Scores for Three Visualization Parameters (Contrast Enhancement, 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 6

7. 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 7

8. Secondary:

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 8

9. Secondary:

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 9

10. Secondary:

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 10

11. Secondary:

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 11

12. Secondary:

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 12

13. Secondary:

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 13

14. Secondary:

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 14

15. Secondary:

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 15

16. Secondary:

Scores for Contrast Enhancement for Lesions for Combined Unenhanced/Gadobutrol-enhanced MRI by Clinical Investigator [ Time Frame: Up to 2 hours after injection of gadobutrol ]

Show Outcome Measure 16

17. 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 17

18. Secondary:

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 Clinical Investigator [ Time Frame: Up to 2 hours after injection of gadobutrol ]

Show Outcome Measure 18

19. 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 19

20. 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 20

21. 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 21

22. 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 22

23. 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 23

24. 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 24

25. 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 25

26. 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 26

27. 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 27

28. 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 28

29. 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 29

30. 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 30

31. 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 31

Serious Adverse Events

Show Serious Adverse Events

Other Adverse Events

Show Other Adverse Events

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:

	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:	NCT00623467 History of Changes
Other Study ID Numbers:	91682
Study First Received:	February 18, 2008
Results First Received:	June 20, 2011
Last Updated:	February 7, 2013
Health Authority:	United States: Food and Drug Administration

To Top