At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 446 enrolled
Drug / intervention
Gadobutrol (Gadavist, Gadovist, BAY86-4875)drug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 3 clinical trial evaluating Gadobutrol (Gadavist, Gadovist, BAY86-4875) for Breast Cancer and Diagnostic Imaging. Completed, enrolled 446 participants across 40 sites in 9 countries.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBreast Cancer, Diagnostic Imaging
CountriesArgentina, Brazil, Colombia, Finland, Germany, Italy, South Korea, Switzerland, United States
Collaborators--
Timeline
Phase 3CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
Enrollment StartFeb 2010
First PostedFeb 2010
Primary CompletionJul 2011
Study CompletionJan 2012
TodayJul 2026
First PostedFeb 12, 2010
Enrollment StartFeb 1, 2010
Primary CompletionJul 1, 2011
Study CompletionJan 1, 2012
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 16.4 years ago
Interventions
Gadobutrol (Gadavist, Gadovist, BAY86-4875)drug
A single bolus injection of gadobutrol 1.0 M 0.1mmol/kg body weight