NCT01067976

Efficacy and Safety of Gadobutrol 1.0 Molar (Gadovist) for Breast MRI

An Open Label, Multi-center, Phase 3 Study With Corresponding Blinded Image Reading to Determine the Efficacy and Safety of a Single Intravenous Injection of 0.1 mmol/kg Body Weight of Gadobutrol 1.0 Molar (Gadovist®) in Patients With Newly Diagnosed Breast Cancer Referred for Contrast-enhanced Breast MRI

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 446 (actual)
• Sponsor: Bayer · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to look at the efficacy (how does it work) and safety of gadobutrol when used for obtaining MR images of both breasts.Women with a recent diagnosis of breast cancer by mammogram (X-ray examination of the breasts) may benefit from MRI of the breasts as MRI may detect additional breast cancers.

Conditions

• Breast Cancer
• Diagnostic Imaging

Interventions

Type	Name	Description
DRUG	Gadobutrol (Gadavist, Gadovist, BAY86-4875)	A single bolus injection of gadobutrol 1.0 M 0.1mmol/kg body weight

Timeline

• Start date: 2010-02-01
• Primary completion: 2011-07-01
• Completion: 2012-01-01
• First posted: 2010-02-12
• Last updated: 2014-11-11
• Results posted: 2014-11-11

Locations

40 sites across 9 countries: United States, Argentina, Brazil, Colombia, Finland, Germany, Italy, South Korea, Switzerland