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

NCT00907530 | Completed Phase 4

• 1 other identifier: MH-123
• Study Type: interventional
• Target: 121
• Locations: 1 country
• Sites: 1

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.

Conditions

Brain Lesions

Outcome Measures

Primary Outcomes (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).

  Day 1 and Day 2

Study Arms (2)

MULTIHANCE

ACTIVE COMPARATOR

gadobenate dimeglumine

Drug: MULTIHANCE:

GADOVIST

ACTIVE COMPARATOR

gadobutrol

Drug: GADOVIST

Interventions

MULTIHANCE: DRUG

MULTIHANCE ® 0.5 M,0.1 mmol/kg

MULTIHANCE

GADOVIST DRUG

GADOVIST ® 1.0 M,0.1 mmol/kg

GADOVIST

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Bracco Diagnostics, Inc: lead

Study Sites (1)

Hamilton Health Sciences Corporation

Hamilton, Ontario, Canada

Location

MeSH Terms

Interventions

gadobenic acid; gadobutrol

Study Officials

• Gianpaolo Pirovano, MD

  Bracco Diagnostics

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 20, 2009
• First Posted: May 22, 2009
• Study Start: September 1, 2009
• Primary Completion: March 1, 2011
• Study Completion: July 1, 2011
• Last Updated: January 5, 2012

Record last verified: 2012-01

Locations

CA (1)