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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
History of Changes
  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:

MedlinePlus related topics: MRI Scans
U.S. FDA Resources

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
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

ClinicalTrials.gov processed this record on May 19, 2013