At a glance
ClinicalIndex Comparison RecordN/ACompleted· 1,537 enrolled
Drug / intervention
MR mammography with Dotaremprocedure
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.
Evaluation of Efficacy and Safety of Dotarem in Magnetic Resonance Mammography
In Brief
An observational study evaluating MR mammography with Dotarem for MR Mammography With Dotarem. Completed, enrolled 1,537 participants.
Detailed Summary
Guerbet conducted a non-interventional post-marketing surveillance study on its Magnetic Resonance Imaging (MRI) contrast agent Dotarem (gadoteric acid/gadoterate meglumine) from September 2011 to December 2013. The aim of this study, which was conducted in accordance with section 67, paragraph 6 of the German drug regulation, Arzneimittelgesetz, was to generate additional data on the diagnostic efficacy, reliability and safety of Dotarem in Magnetic Resonance (MR) mammography.
Study Details
Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsMR Mammography With Dotarem
Countries--
Collaborators--
Timeline
N/ACompletedFinished
201220132014201520162017201820192020202120222023202420252026
Enrollment StartSep 2011
Primary CompletionOct 2013
Study CompletionDec 2013
First PostedFeb 2017
TodayJul 2026
First PostedFeb 2, 2017
Enrollment StartSep 1, 2011
Primary CompletionOct 1, 2013
Study CompletionDec 1, 2013
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 9.4 years ago
Interventions
MR mammography with Dotaremprocedure