NCT00709852

Safety and Efficacy of Gadobutrol 1.0 Molar (Gadavist) in Patients for Central Nervous System (CNS) Imaging

A Multicenter, Randomized, Double-blind, Crossover, Phase 3 Study to Determine the Safety and Efficacy of Gadobutrol 1.0 Molar (Gadavist) in Patients Referred for Contrast-enhanced MRI of the Central Nervous System (CNS)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 402 (actual)
• Sponsor: Bayer · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study involves the use of Magnetic Resonance Imaging (MRI) contrast agents called gadobutrol (Gadavist) Injection and ProHance Injection. The purpose of this study is to look at the safety (what are the side effects) and efficacy (how well does it work) of gadobutrol when used for taking MR images of the brain and spine. The results of the MRI with gadobutrol Injection will be compared to the results of MR images taken without contrast and with the results of the MR images taken with ProHance.

Detailed description

Issues on safety will be addressed in Adverse Events section.

Conditions

• Diagnostic Imaging
• Central Nervous System Diseases

Interventions

Type	Name	Description
DRUG	Gadobutrol (Gadavist, Gadovist, BAY86-4875)	Participants received a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous)
DRUG	Gadoteridol (ProHance)	Participants received a single dose of gadoteridol at the approved dose, 0.1 mmol/kg bw, via i.v.

Timeline

• Start date: 2008-06-01
• Primary completion: 2009-04-01
• Completion: 2009-04-01
• First posted: 2008-07-03
• Last updated: 2014-12-30
• Results posted: 2012-03-06

Locations

79 sites across 8 countries: United States, Australia, Austria, Colombia, Germany, India, Japan, Switzerland