COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC:

Get the latest research information from NIH: Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00907530
Recruitment Status : Completed
First Posted : May 22, 2009
Last Update Posted : January 5, 2012
Information provided by (Responsible Party):
Bracco Diagnostics, Inc

Brief Summary:
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 or disease Intervention/treatment Phase
Brain Lesions Drug: MULTIHANCE: Drug: GADOVIST Phase 4

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 121 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, 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
Study Start Date : September 2009
Actual Primary Completion Date : March 2011
Actual Study Completion Date : July 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: MRI Scans

Arm Intervention/treatment
Active Comparator: MULTIHANCE
gadobenate dimeglumine
MULTIHANCE ® 0.5 M,0.1 mmol/kg

Active Comparator: GADOVIST
GADOVIST ® 1.0 M,0.1 mmol/kg

Primary Outcome Measures :
  1. 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 ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

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 identifier (NCT number): NCT00907530

Layout table for location information
Canada, Ontario
Hamilton Health Sciences Corporation
Hamilton, Ontario, Canada
Sponsors and Collaborators
Bracco Diagnostics, Inc
Layout table for investigator information
Study Director: Gianpaolo Pirovano, MD Bracco Diagnostics
Layout table for additonal information
Responsible Party: Bracco Diagnostics, Inc Identifier: NCT00907530    
Other Study ID Numbers: MH-123
First Posted: May 22, 2009    Key Record Dates
Last Update Posted: January 5, 2012
Last Verified: January 2012