NCT00907530

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

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 121 (actual)
• Sponsor: Bracco Diagnostics, Inc · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DRUG	MULTIHANCE:	MULTIHANCE ® 0.5 M,0.1 mmol/kg
DRUG	GADOVIST	GADOVIST ® 1.0 M,0.1 mmol/kg

Timeline

• Start date: 2009-09-01
• Primary completion: 2011-03-01
• Completion: 2011-07-01
• First posted: 2009-05-22
• Last updated: 2012-01-05

Locations

1 site across 1 country: Canada