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: April 8, 2014
Last verified: April 2014
  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:
  • Non-inferiority of each exam based on pre-dose and post dose images [ Time Frame: Up to 14 days ] [ Designated as safety issue: No ]
    To show non-inferiority of a 0.1 mmol/kg dose of PROHANCE as compared to 0.1 mmol/kg dose of GADOVIST/GADAVIST, in terms of the by-subject global diagnostic preference between exams (i.e., based on predose + postdose image sets).


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 ProHance Drug: Gadoteridol
ProHance 0.1 mmol/kg
Active Comparator: MRI with Gadovist/Gadavist Drug: gadobutrol
Gadovist/Gadavist 0.1 mmol/kg

  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
Sponsors and Collaborators
Bracco Diagnostics, Inc
Investigators
Study Director: Gianpaolo Pirovano, MD Bracco Diagnostics, Inc
  More Information

No publications provided

Responsible Party: Bracco Diagnostics, Inc
ClinicalTrials.gov Identifier: NCT01613417     History of Changes
Other Study ID Numbers: PH-107
Study First Received: June 4, 2012
Last Updated: April 8, 2014
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 October 23, 2014