Comparison of Prohance® With Gadovist®/Gadavist™ in Magnetic Resonance Imaging (MRI) of the Brain (TRUTH)
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| ClinicalTrials.gov Identifier: NCT01613417 |
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Recruitment Status :
Completed
First Posted : June 7, 2012
Results First Posted : June 3, 2015
Last Update Posted : July 1, 2015
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Sponsor:
Bracco Diagnostics, Inc
Information provided by (Responsible Party):
Bracco Diagnostics, Inc
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| Study Type | Interventional |
|---|---|
| Study Design | Allocation: Randomized; Intervention Model: Crossover Assignment; Masking: Triple (Participant, Investigator, Outcomes Assessor); Primary Purpose: Diagnostic |
| Condition |
Brain Disease |
| Interventions |
Drug: gadoteridol Drug: gadobutrol |
| Enrollment | 229 |
Participant Flow
| Recruitment Details | 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 | 229 patients were enrolled and signed informed consent. Each enrolled patient was randomized and dosed with at least one contrast agent. |
| Arm/Group Title | Sequence 1 (ProHance Then Gadovist/Gadavist) | Sequence 2 (Gadovist/Gadavist Then ProHance) |
|---|---|---|
 Arm/Group Description |
Patients randomized to receive ProHance first | Patients randomized to receive Gadovist/Gadavist first |
| Period Title: First Injection | ||
| Started | 113 | 116 |
| Completed | 113 | 116 |
| Not Completed | 0 | 0 |
| Period Title: Washout (no Second Injection/MRI) | ||
| Started | 113 | 116 |
| Completed | 100 | 109 |
| Not Completed | 13 | 7 |
| Reason Not Completed | ||
| Withdrawal by Subject | 13 | 7 |
| Period Title: Second Injection | ||
| Started | 100 | 109 |
| Completed | 100 | 109 |
| Not Completed | 0 | 0 |
Baseline Characteristics
| Arm/Group Title | ProHance Then Gadovist/Gadavist | Gadovist/Gadavist Then ProHance | Total | |
|---|---|---|---|---|
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Arm/Group Description |
Per Protocol=patients who completed both exams, had global paired image data available, and had no major protocol violations | Per Protocol=patients who completed both exams, had global paired image data available, and had no major protocol violations | Total of all reporting groups | |
| Overall Number of Baseline Participants | 93 | 105 | 198 | |
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Baseline Analysis Population Description |
Per Protocol
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Age, Categorical
Measure Type: Count of Participants Unit of measure: Participants |
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| Number Analyzed | 93 participants | 105 participants | 198 participants | |
| <=18 years |
0 0.0%
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0 0.0%
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0 0.0%
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| Between 18 and 65 years |
70 75.3%
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70 66.7%
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140 70.7%
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| >=65 years |
23 24.7%
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35 33.3%
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58 29.3%
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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| Number Analyzed | 93 participants | 105 participants | 198 participants | |
| 54.5 (14.27) | 55.9 (14.29) | 55.2 (14.31) | ||
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Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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| Number Analyzed | 93 participants | 105 participants | 198 participants | |
| Female |
50 53.8%
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58 55.2%
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108 54.5%
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| Male |
43 46.2%
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47 44.8%
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90 45.5%
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Race (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
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| Number Analyzed | 93 participants | 105 participants | 198 participants | |
| American Indian or Alaska Native |
0 0.0%
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0 0.0%
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0 0.0%
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| Asian |
3 3.2%
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1 1.0%
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4 2.0%
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| Native Hawaiian or Other Pacific Islander |
0 0.0%
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0 0.0%
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0 0.0%
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| Black or African American |
0 0.0%
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2 1.9%
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2 1.0%
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| White |
88 94.6%
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102 97.1%
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190 96.0%
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| More than one race |
2 2.2%
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0 0.0%
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2 1.0%
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| Unknown or Not Reported |
0 0.0%
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0 0.0%
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0 0.0%
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Region of Enrollment
Measure Type: Number Unit of measure: Participants |
Number Analyzed | 93 participants | 105 participants | 198 participants |
| United States | 46 | 46 | 92 | |
| Europe | 39 | 51 | 90 | |
| Canada | 8 | 8 | 16 | |
Outcome Measures
Adverse Events
Limitations and Caveats
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
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.
Study results may be presented at scientific symposia or published in a peer-review journal after review by sponsor in accordance with the guidelines set forth in the applicable publication or financial agreement
Results Point of Contact
| Name/Title: | Gianpaolo Pirovano, MD |
| Organization: | Executive Director, MRI |
| Phone: | 609-514-2226 |
| EMail: | gianpaolo.pirovano@diag.bracco.com |
| Responsible Party: | Bracco Diagnostics, Inc |
| ClinicalTrials.gov Identifier: | NCT01613417 |
| Other Study ID Numbers: |
PH-107 |
| First Submitted: | June 4, 2012 |
| First Posted: | June 7, 2012 |
| Results First Submitted: | April 28, 2015 |
| Results First Posted: | June 3, 2015 |
| Last Update Posted: | July 1, 2015 |