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

Bracco Diagnostics, Inc1 site in 1 country121 target enrollmentSeptember 2009

ConditionsBrain Lesions

InterventionsGADOVIST

DrugsMULTIHANCE:GADOVIST

Overview

Phase: Phase 4
Intervention: GADOVIST
Conditions: Brain Lesions
Sponsor: Bracco Diagnostics, Inc
Enrollment: 121
Locations: 1
Primary Endpoint: 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).
Status: Completed
Last Updated: 14 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

September 2009

End Date

July 2011

Last Updated

14 years ago

Study Type

Interventional

Study Design

Crossover

Sex

All

Investigators

Sponsor

Bracco Diagnostics, Inc

Responsible Party

Sponsor

Eligibility 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.

Arms & Interventions

GADOVIST

gadobutrol

Intervention: GADOVIST

Outcomes

Primary Outcomes

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