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Study to Compare MultiHance With Gadovist in Magnetic Resonance Imaging (MRI) of the Brain (MERIT)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bracco Diagnostics, Inc
ClinicalTrials.gov Identifier:
NCT00907530
First received: May 20, 2009
Last updated: January 4, 2012
Last verified: January 2012
  Purpose

This study is being conducted as a phase IV, double-blind, multi-center, randomized, crossover trial aimed at a within-subject comparison of MULTIHANCE and GADOVIST at a dose of 0.1 mmol/kg, in terms of qualitative and quantitative assessment of unenhanced MRI (UE MRI) and contrast-enhanced MRI (CE MRI) for the visualization of brain disease.


Condition Intervention Phase
Brain Lesions
Drug: MULTIHANCE:
Drug: GADOVIST
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Diagnostic
Official Title: Phase IV, Double-Blind, Multi-Center, Randomized, Crossover Study to Compare 0.1 mmol/kg OF MULTIHANCE® WITH 0.1 mmol/kg OF GADOVIST® in Magnetic Resonance Imaging (MRI) of the Brain

Resource links provided by NLM:


Further study details as provided by Bracco Diagnostics, Inc:

Primary Outcome Measures:
  • To show superiority of a 0.1 mmol/kg dose of MULTIHANCE as compared to 0.1 mmol/kg dose of GADOVIST, in terms of the by-subject global diagnostic preference between exams (i.e., based on predose + postdose image sets). [ Time Frame: Day 1 and Day 2 ] [ Designated as safety issue: No ]

Enrollment: 121
Study Start Date: September 2009
Study Completion Date: July 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: MULTIHANCE
gadobenate dimeglumine
Drug: MULTIHANCE:
MULTIHANCE ® 0.5 M,0.1 mmol/kg
Active Comparator: GADOVIST
gadobutrol
Drug: GADOVIST
GADOVIST ® 1.0 M,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:

  • Enroll subjects in this study if they meet the following inclusion criteria:
  • Are at least 18 years of age or older
  • Are able to give written informed consent and are willing to comply with the protocol requirements
  • Are scheduled to undergo MRI
  • Are willing to undergo two MRI procedures within 14 days
  • Have confirmed or are highly suspected to have brain tumor(s) (primary or secondary), as determined by:
  • clinical/neurological symptomatology;
  • diagnostic testing, such as CT or previous MRI examinations; or
  • have had recent surgery within 6 months and are to be evaluated for recurrence.

Exclusion Criteria:

  • Exclude subjects from this study if they do not fulfill the inclusion criteria, or if any of the following conditions are observed.
  • Are pregnant or lactating females. Exclude the possibility of pregnancy:
  • by testing on site at the institution (serum or urine bHCG) within 24 h prior to the start of each investigational product administration
  • by history (i.e., tubal ligation or hysterectomy)
  • post menopausal with a minimum of 1 year without menses
  • Have any known allergy to one or more of the ingredients in the investigational product, 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
  • Have suffered a stroke within a year
  • Have received or are scheduled to receive any other contrast medium in the 24 h preceding through the 24 h following Exam 1, and in the 24 h preceding through the 24 h 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 h post-administration of the second investigational product.
  • Have moderate-to-severe renal impairment, defined as a GFR/eGFR < 60 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
  • Have any medical condition or other circumstances which would significantly decrease the chances of obtaining reliable data, achieving study objectives, or completing the study and/or post-dose follow-up examinations
  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: NCT00907530

Locations
Canada, Ontario
Hamilton Health Sciences Corporation
Hamilton, Ontario, Canada
Sponsors and Collaborators
Bracco Diagnostics, Inc
Investigators
Study Director: Gianpaolo Pirovano, MD Bracco Diagnostics
  More Information

No publications provided

Responsible Party: Bracco Diagnostics, Inc
ClinicalTrials.gov Identifier: NCT00907530     History of Changes
Other Study ID Numbers: MH-123
Study First Received: May 20, 2009
Last Updated: January 4, 2012
Health Authority: European Union: European Medicines Agency
Canada: Health Canada

Additional relevant MeSH terms:
Gadobenic acid
Gadobutrol
Gadolinium DTPA
Contrast Media
Diagnostic Uses of Chemicals
Pharmacologic Actions

ClinicalTrials.gov processed this record on November 20, 2014