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
  Purpose

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 Intervention Phase
Brain Disease
Drug: gadoteridol
Drug: gadobutrol
Phase 4

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
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)

Resource links provided by NLM:


Further study details as provided by Bracco Diagnostics, Inc:

Primary Outcome Measures:
  • Global Diagnostic Preference Between the Two Exams [ Time Frame: Comparison of image sets obtained within 2 to 14 days ] [ Designated as safety issue: No ]
    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:
  • Lesion Border Delineation [ Time Frame: Comparison of image sets obtained within 2 to 14 days ] [ Designated as safety issue: No ]
    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.

  • Lesion Internal Morphology [ Time Frame: Comparison of image sets obtained within 2 to 14 days ] [ Designated as safety issue: No ]
    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.

  • Extent of Disease [ Time Frame: Comparison of image sets obtained within 2 to 14 days ] [ Designated as safety issue: No ]
    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.

  • Lesion Contrast Enhancement [ Time Frame: Comparison of image sets obtained within 2 to 14 days ] [ Designated as safety issue: No ]
    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.

  • Lesion to Background Ratio on Post T1-weighed Spin Echo Images [ Time Frame: 5-10 minutes Postdose ] [ Designated as safety issue: No ]
    Mean of difference in signal intensity postdose (ProHance - Gadovist/Gadavist)

  • Percentage Signal Intensity Enhancement on Postdose Images [ Time Frame: 5-10 minutes Postdose ] [ Designated as safety issue: No ]
    Mean difference in percentage signal intensity enhancement on postdose T1-weighted SE/FSE images (ProHance - Gadovist/Gadavist)

  • Lesion Detection [ Time Frame: 5-10 minutes Postdose ] [ Designated as safety issue: No ]
    Lesion detection rate by contrast agent and reader

  • Accuracy for Tumor Characterization [ Time Frame: 5-10 minutes Postdose ] [ Designated as safety issue: No ]
    Blinded reader assessment of accuracy of tumor characterization (benign/malignant) - patient level assessment


Enrollment: 229
Study Start Date: August 2012
Study Completion Date: April 2014
Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01613417

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

Publications:
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

Keywords provided by Bracco Diagnostics, Inc:
Have confirmed or are highly suspected of brain disease

Additional relevant MeSH terms:
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Gadobutrol
Gadoteridol
Contrast Media
Diagnostic Uses of Chemicals
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 27, 2015