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



Status:Archived
Conditions:Breast Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:Any
Updated:7/1/2011
Start Date:February 2010
End Date:May 2011

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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


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.



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Austin, Texas
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Boston, Massachusetts
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Centralia, Illinois
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Santa Clara, California 95051
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Santa Clara, CA
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