Multihance at 3 Tesla in Brain Tumors

This study has been completed.
Sponsor:
Information provided by:
Bracco Diagnostics, Inc
ClinicalTrials.gov Identifier:
NCT00395863
First received: September 12, 2006
Last updated: September 24, 2010
Last verified: September 2010
Results First Received: March 30, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Crossover Assignment;   Masking: Double Blind (Subject, Investigator, Outcomes Assessor);   Primary Purpose: Diagnostic
Condition: Brain Tumor
Interventions: Drug: Multihance
Drug: Arm 2 - Magnevist

  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
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
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
47 patients enrolled (signed informed consent); 46 were randomized and dosed.

Reporting Groups
  Description
MultiHance, Then Magnevist 0.1 mmol/kg injection of each product
Magnevist, Then MultiHance 0.1 mmol/kg injection of each product

Participant Flow:   Overall Study
    MultiHance, Then Magnevist     Magnevist, Then MultiHance  
STARTED     23     23  
COMPLETED     21     20  
NOT COMPLETED     2     3  
Patients did not complete both exams                 2                 3  



  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.
No text entered.

Reporting Groups
  Description
MultiHance, Then Magnevist 0.1 mmol/kg injection of each product
Magnevist, Then MultiHance 0.1 mmol/kg injection of each product
Total Total of all reporting groups

Baseline Measures
    MultiHance, Then Magnevist     Magnevist, Then MultiHance     Total  
Number of Participants  
[units: participants]
  23     23     46  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     19     20     39  
>=65 years     4     3     7  
Age  
[units: years]
Mean ± Standard Deviation
  50.79  ± 15.497     48.08  ± 16.064     49.43  ± 15.667  
Gender  
[units: participants]
     
Female     12     9     21  
Male     11     14     25  
Race (NIH/OMB)  
[units: participants]
     
American Indian or Alaska Native     0     0     0  
Asian     0     0     0  
Native Hawaiian or Other Pacific Islander     0     0     0  
Black or African American     0     3     3  
White     23     19     42  
More than one race     0     1     1  
Unknown or Not Reported     0     0     0  
Region of Enrollment  
[units: participants]
     
United States     23     23     46  



  Outcome Measures
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1.  Primary:   Global Diagnostic Preference Between the Two Exams   [ Time Frame: Postdose Images for MultiHance Exam and for Magnevist Exam Compared ]

2.  Secondary:   Lesion Border Delineation   [ Time Frame: Postdose Images for MultiHance Exam and for Magnevist Exam Compared ]

3.  Secondary:   Lesion Contrast Enhancement Between the Two Exams   [ Time Frame: Postdose Images for MultiHance Exam and for Magnevist Exam Compared ]

4.  Secondary:   Lesion-to-brain Ratio (LBR) for Each Lesion - Reader 1   [ Time Frame: Predose and immediately postdose ]

5.  Secondary:   Lesion-to-brain Ratio (LBR) for Each Lesion - Reader 2   [ Time Frame: Predose and immediately postdose ]

6.  Secondary:   Lesion-to-brain Ratio (LBR) for Each Lesion - Reader 3   [ Time Frame: Predose and immediately postdose ]

7.  Secondary:   Contrast-to-noise Ratio (CNR) for Each Lesion - Reader 1   [ Time Frame: Predose and immediately postdose ]

8.  Secondary:   Contrast-to-noise Ratio (CNR) for Each Lesion - Reader 2   [ Time Frame: Predose and immediately postdose ]

9.  Secondary:   Contrast-to-noise Ratio (CNR) for Each Lesion - Reader 3   [ Time Frame: Predose and immediately postdose ]

10.  Secondary:   Percentage of Contrast Enhancement of the Lesion - Reader 1   [ Time Frame: Postdose ]

11.  Secondary:   Percentage of Contrast Enhancement of the Lesion - Reader 2   [ Time Frame: Postdose ]

12.  Secondary:   Percentage of Contrast Enhancement of the Lesion - Reader 3   [ Time Frame: Postdose ]


  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: Gianpaolo Pirovano
Organization: Executive Director, Head Corporate Medical Development
phone: 609-514-2226
e-mail: gianpaolo.pirovano@diag.bracco.com


Publications of Results:

Responsible Party: Gianpaolo Pirovano, MD, Executive Director, Corporate Medical Development, Bracco Dianostics, Inc
ClinicalTrials.gov Identifier: NCT00395863     History of Changes
Other Study ID Numbers: MH 126
Study First Received: September 12, 2006
Results First Received: March 30, 2009
Last Updated: September 24, 2010
Health Authority: United States: Institutional Review Board