Comparison of Prohance® With Gadovist®/Gadavist™ in Magnetic Resonance Imaging (MRI) of the Brain (TRUTH)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bracco Diagnostics, Inc
ClinicalTrials.gov Identifier:
NCT01613417
First received: June 4, 2012
Last updated: June 4, 2015
Last verified: June 2015
Results First Received: April 28, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Crossover Assignment;   Masking: Double Blind (Subject, Investigator, Outcomes Assessor);   Primary Purpose: Diagnostic
Condition: Brain Disease
Interventions: Drug: gadoteridol
Drug: gadobutrol

  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 229 patients were recruited from September 2012 through November 2013 at 19 clinical trial sites. Off-site assessment of the images was performed between 21 January and 3 April 2014 by 3 board-certified neuroradiologists blinded as to which contrast agent was used, patient clinical information, and the results of other imaging studies.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
229 patients were enrolled and signed informed consent. Each enrolled patient was randomized and dosed with at least one contrast agent.

Reporting Groups
  Description
Sequence 1 (ProHance Then Gadovist/Gadavist) Patients randomized to receive ProHance first
Sequence 2 (Gadovist/Gadavist Then ProHance) Patients randomized to receive Gadovist/Gadavist first

Participant Flow for 3 periods

Period 1:   First Injection
    Sequence 1 (ProHance Then Gadovist/Gadavist)     Sequence 2 (Gadovist/Gadavist Then ProHance)  
STARTED     113     116  
COMPLETED     113     116  
NOT COMPLETED     0     0  

Period 2:   Washout (no Second Injection/MRI)
    Sequence 1 (ProHance Then Gadovist/Gadavist)     Sequence 2 (Gadovist/Gadavist Then ProHance)  
STARTED     113     116  
COMPLETED     100     109  
NOT COMPLETED     13     7  
Withdrawal by Subject                 13                 7  

Period 3:   Second Injection
    Sequence 1 (ProHance Then Gadovist/Gadavist)     Sequence 2 (Gadovist/Gadavist Then ProHance)  
STARTED     100     109  
COMPLETED     100     109  
NOT COMPLETED     0     0  



  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.
Per Protocol

Reporting Groups
  Description
ProHance Then Gadovist/Gadavist Per Protocol=patients who completed both exams, had global paired image data available, and had no major protocol violations
Gadovist/Gadavist Then ProHance Per Protocol=patients who completed both exams, had global paired image data available, and had no major protocol violations
Total Total of all reporting groups

Baseline Measures
    ProHance Then Gadovist/Gadavist     Gadovist/Gadavist Then ProHance     Total  
Number of Participants  
[units: participants]
  93     105     198  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     70     70     140  
>=65 years     23     35     58  
Age  
[units: years]
Mean (Standard Deviation)
  54.5  (14.27)     55.9  (14.29)     55.2  (14.31)  
Gender  
[units: participants]
     
Female     50     58     108  
Male     43     47     90  
Race (NIH/OMB)  
[units: participants]
     
American Indian or Alaska Native     0     0     0  
Asian     3     1     4  
Native Hawaiian or Other Pacific Islander     0     0     0  
Black or African American     0     2     2  
White     88     102     190  
More than one race     2     0     2  
Unknown or Not Reported     0     0     0  
Region of Enrollment  
[units: participants]
     
United States     46     46     92  
Europe     39     51     90  
Canada     8     8     16  



  Outcome Measures
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1.  Primary:   Global Diagnostic Preference Between the Two Exams   [ Time Frame: Comparison of image sets obtained within 2 to 14 days ]

2.  Secondary:   Lesion Border Delineation   [ Time Frame: Comparison of image sets obtained within 2 to 14 days ]

3.  Secondary:   Lesion Internal Morphology   [ Time Frame: Comparison of image sets obtained within 2 to 14 days ]

4.  Secondary:   Extent of Disease   [ Time Frame: Comparison of image sets obtained within 2 to 14 days ]

5.  Secondary:   Lesion Contrast Enhancement   [ Time Frame: Comparison of image sets obtained within 2 to 14 days ]

6.  Secondary:   Lesion to Background Ratio on Post T1-weighed Spin Echo Images   [ Time Frame: 5-10 minutes Postdose ]

7.  Secondary:   Percentage Signal Intensity Enhancement on Postdose Images   [ Time Frame: 5-10 minutes Postdose ]

8.  Secondary:   Lesion Detection   [ Time Frame: 5-10 minutes Postdose ]

9.  Secondary:   Accuracy for Tumor Characterization   [ Time Frame: 5-10 minutes 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
Histologic confirmation of disease available for only 139/198 patients in the PP analysis. Of these, 128 patients had confirmed brain tumors and were available for the analyses of diagnostic performance (tumor detection and tumor characterization).


  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, MD
Organization: Executive Director, MRI
phone: 609-514-2226
e-mail: gianpaolo.pirovano@diag.bracco.com


Publications of Results:

Responsible Party: Bracco Diagnostics, Inc
ClinicalTrials.gov Identifier: NCT01613417     History of Changes
Other Study ID Numbers: PH-107
Study First Received: June 4, 2012
Results First Received: April 28, 2015
Last Updated: June 4, 2015
Health Authority: United States: Institutional Review Board
Czech Republic: Ethics Committee
Poland: Ethics Committee