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

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ClinicalTrials.gov Identifier: NCT01613417
Recruitment Status : Completed
First Posted : June 7, 2012
Results First Posted : June 3, 2015
Last Update Posted : July 1, 2015
Sponsor:
Information provided by (Responsible Party):
Bracco Diagnostics, Inc

Study Description
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Brief Summary:
This study aims at a direct comparison between ProHance (0.1 mmol/kg) and a validated comparator Gadovist/Gadavist (0.1 mmol/kg) in a crossover intra-individual design in subjects with brain tumors to confirm the identical overall technical and diagnostic performance of the two MR contrast agents.

Condition or disease Intervention/treatment Phase
Brain Disease Drug: gadoteridol Drug: gadobutrol Phase 4

Detailed Description:
Adult patients were given two MRI exams, one after injection of ProHance (0.1 mmol/kg) and one after injection of Gadovist/Gadavist (0.1 mmol/kg). The exams were performed with identical equipment and imaging parameters with the order of the two exams randomized and 2-14 days between the first and the second MRI exam. Image data was evaluated by 3 expert neuroradiologist blinded to the agent administered and patient clinical data.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 229 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: Phase IV, Double-blind, Multi-center, Randomized, Crossover Study to Compare 0.1 mmol/kg of Prohance® With 0.1 mmol/kg of Gadovist®/Gadavist™ in Magnetic Resonance Imaging (MRI) of the Brain (TRUTH)
Study Start Date : August 2012
Actual Primary Completion Date : April 2014
Actual Study Completion Date : April 2014

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: MRI with Gadoteridol
MRI after 0.1 mmol/kg IV ProHance, then with 0.1 mmol/kg Gadovist/Gadavist. MRI performed after both agents with identical sequences.
 Drug: gadoteridol
ProHance 0.1 mmol/kg
Other Name: ProHance

Drug: gadobutrol
Gadovist/Gadavist 0.1 mmol/kg
Other Name: Gadovist, Gadavist
Active Comparator: MRI with Gadobutrol
MRI after 0.1 mmol/kg IV Gadovist/Gadavist, then with 0.1 mmol/kg ProHance. MRI performed after both agents with identical sequences.
 Drug: gadoteridol
ProHance 0.1 mmol/kg
Other Name: ProHance

Drug: gadobutrol
Gadovist/Gadavist 0.1 mmol/kg
Other Name: Gadovist, Gadavist


Outcome Measures
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Primary Outcome Measures :
  1. Global Diagnostic Preference Between the Two Exams [ Time Frame: Comparison of image sets obtained within 2 to 14 days ]
    Assessed by 3 blinded readers for each of the 198 patients who had post-dose exams for both ProHance and Gadovist/Gadavist. Readers assessed whether images with ProHance were preferred or images with Gadovist/Gadavist were preferred, or whether images after both exams were considered equal.


Secondary Outcome Measures :
  1. Lesion Border Delineation [ Time Frame: Comparison of image sets obtained within 2 to 14 days ]
    Assessed by 3 blinded readers for each of the 198 patients who had post-dose exams for both ProHance and Gadovist/Gadavist. Readers assessed whether images with ProHance were preferred or images with Gadovist/Gadavist were preferred, or whether images after both exams were considered equal.

  2. Lesion Internal Morphology [ Time Frame: Comparison of image sets obtained within 2 to 14 days ]
    Assessed by 3 blinded readers for each of the 198 patients who had post-dose exams for both ProHance and Gadovist/Gadavist. Readers assessed whether images with ProHance were preferred or images with Gadovist/Gadavist were preferred, or whether images after both exams were considered equal.

  3. Extent of Disease [ Time Frame: Comparison of image sets obtained within 2 to 14 days ]
    Assessed by 3 blinded readers for each of the 198 patients who had post-dose exams for both ProHance and Gadovist/Gadavist. Readers assessed whether images with ProHance were preferred or images with Gadovist/Gadavist were preferred, or whether images after both exams were considered equal.

  4. Lesion Contrast Enhancement [ Time Frame: Comparison of image sets obtained within 2 to 14 days ]
    Assessed by 3 blinded readers for each of the 198 patients who had post-dose exams for both ProHance and Gadovist/Gadavist. Readers assessed whether images with ProHance were preferred or images with Gadovist/Gadavist were preferred, or whether images after both exams were considered equal.

  5. Lesion to Background Ratio on Post T1-weighed Spin Echo Images [ Time Frame: 5-10 minutes Postdose ]
    Mean of difference in signal intensity postdose (ProHance - Gadovist/Gadavist)

  6. Percentage Signal Intensity Enhancement on Postdose Images [ Time Frame: 5-10 minutes Postdose ]
    Mean difference in percentage signal intensity enhancement on postdose T1-weighted SE/FSE images (ProHance - Gadovist/Gadavist)

  7. Lesion Detection [ Time Frame: 5-10 minutes Postdose ]
    Lesion detection rate by contrast agent and reader

  8. Accuracy for Tumor Characterization [ Time Frame: 5-10 minutes Postdose ]
    Blinded reader assessment of accuracy of tumor characterization (benign/malignant) - patient level assessment


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Are scheduled to undergo MRI
  • Are willing to undergo two MRI procedures within 14 days
  • Have confirmed or are highly suspected of brain disease likely to enhance as determined by the following:
  • Clinical/neurological symptomatology;
  • Diagnostic testing, such as CT or previous MRI examinations; or
  • Have had previous brain surgery and are to be evaluated for recurrence.

Exclusion Criteria:

  • Are pregnant or lactating females. Exclude the possibility of pregnancy:
  • by testing on site at the institution within 24 hours prior to the start of each investigational product administration; or
  • by history (i.e., tubal ligation or hysterectomy); or
  • post menopausal with a minimum of 1 year without menses
  • Have any known allergy to one or more of the ingredients in the investigational products, or have a history of hypersensitivity to any metals
  • Have congestive heart failure (class IV according to the classification of the New York Heart Association; see Appendix A)
  • Have suffered a stroke within a year
  • Have received or are scheduled to receive any other contrast medium in the 24 hours preceding through the 24 hours following Exam 1, and in the 24 hours preceding through the 24 hours following Exam 2
  • Have received or are scheduled to receive an investigational compound and/or medical device within 30 days before admission into the present study, through the 24 hours post-administration of the second investigational product.
  • Have moderate-to-severe renal impairment, defined as a GFR/eGFR < 45 mL/min.
  • Have been previously entered into this study
  • Have received or are scheduled for one of the following:
  • Surgery within three weeks prior to the first examination or between the two examinations
  • Initiation of steroid therapy between the two examinations
  • Radiosurgery between the two examinations
  • Have any contraindications to MRI such as a pace-maker, magnetic material (i.e., surgical clips) or any other conditions that would preclude proximity to a strong magnetic field.
  • Are suffering from severe claustrophobia
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01613417


Locations
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United States, New Jersey
Holy Name Medical Center
Teaneck, New Jersey, United States, 07666
Sponsors and Collaborators
Bracco Diagnostics, Inc
Investigators
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Study Director: Gianpaolo Pirovano, MD Bracco Diagnostics, Inc
More Information
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Publications of Results:

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Responsible Party: Bracco Diagnostics, Inc
ClinicalTrials.gov Identifier: NCT01613417    
Other Study ID Numbers: PH-107
First Posted: June 7, 2012    Key Record Dates
Results First Posted: June 3, 2015
Last Update Posted: July 1, 2015
Last Verified: June 2015
Keywords provided by Bracco Diagnostics, Inc:
Have confirmed or are highly suspected of brain disease
Additional relevant MeSH terms:
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Brain Diseases
Central Nervous System Diseases
Nervous System Diseases