CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 44,456 enrolled
Drug / intervention
MRI with Dotaremprocedure
Likely dose
Not stated in record
Key inclusion· 1
  • ✓Patients undergoing routine MRI with Dotarem contrast medium
Key exclusion· 0

None specified.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03048006
NCT03048006N/ACompleted
CompareCT.gov

Evaluation of Dotarem Safety

Guerbet·observational·Posted Feb 9, 2017·Updated May 2, 2017

In Brief

An observational study evaluating MRI with Dotarem for Contrast-enhanced MRI With Dotarem. Completed, enrolled 44,456 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). The aim of this study, which was conducted in accordance with section 67, paragraph 6 of the German drug regulation, Arzneimittelgesetz, was to gain additional insights into the diagnostic efficacy, reliability and safety of Dotarem in routine practice using the most up-to-date MRI techniques and application methods.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsContrast-enhanced MRI With Dotarem
Countries--
Collaborators--

Timeline

N/ACompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedFeb 9, 2017
Enrollment StartJan 1, 2011
Primary CompletionDec 1, 2013
TodayJul 2, 2026
Enrollment to primary: 2.9 yearsPosted 9.4 years ago

Interventions

MRI with Dotaremprocedure