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

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

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.

Study Overview

• Status: Completed
• Conditions: Brain Lesions
• Intervention / Treatment: Drug: MULTIHANCE:; Drug: GADOVIST

• Study Type: Interventional
• Enrollment (Actual): 121
• Phase: Phase 4

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Hamilton, Ontario, Canada
      • Hamilton Health Sciences Corporation

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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).	Day 1 and Day 2

Collaborators and Investigators

• Sponsor: Bracco Diagnostics, Inc
• Investigators: Study Director: Gianpaolo Pirovano, MD, Bracco Diagnostics

Study record dates

Study Major Dates

• Study Start: September 1, 2009
• Primary Completion (Actual): March 1, 2011
• Study Completion (Actual): July 1, 2011

Study Registration Dates

• First Submitted: May 20, 2009
• First Submitted That Met QC Criteria: May 21, 2009
• First Posted (Estimate): May 22, 2009

Study Record Updates

• Last Update Posted (Estimate): January 5, 2012
• Last Update Submitted That Met QC Criteria: January 4, 2012
• Last Verified: January 1, 2012

More Information

Terms related to this study

• Other Study ID Numbers: MH-123