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:
NCT00623467
First received: February 18, 2008
Last updated: January 16, 2014
Last verified: January 2014
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
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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 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
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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.
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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
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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 ]

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 ]

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 ]

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 ]

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 ]

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 ]

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 ]

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 ]

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 ]

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 ]

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 ]

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 ]

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 ]

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 ]

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 ]

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 ]

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 ]

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 ]

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 ]

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 ]

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 ]

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 ]

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 ]

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 ]

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 ]

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 ]

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 ]

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 ]

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 ]

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 ]

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 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
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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:
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: NCT00623467     History of Changes
Other Study ID Numbers: 91682
Study First Received: February 18, 2008
Results First Received: June 20, 2011
Last Updated: January 16, 2014
Health Authority: United States: Food and Drug Administration