Post-marketing Surveillance Study for Evaluation of Dotarem Safety

Completed

• Conditions: Contrast-enhanced MRI With Dotarem
• Interventions: Procedure: MRI with Dotarem

• Registration Number: NCT03048006
• Lead Sponsor: Guerbet

Brief 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.

Detailed Description

Diagnostic efficacy was assessed by the following endpoints: diagnostic value ("yes"/"no") and imaging quality (5-step scale from "excellent" to "very poor"). Safety was evaluated on the basis of the frequency and seriousness of adverse events that occurred following Dotarem injection.

Study Timeline

• Study Start: 2011-01
• Primary Completion: 2013-12
• Study Completion: 2013-12
• Study First Submitted: 2017-02-01
• Study First Submitted QC: 2017-02-07
• Study First Posted: 2017-02-09
• Status Verified: 2017-03
• Results First Submitted: 2017-03-22
• Results First Submitted QC: 2017-03-22
• Last Update Submitted: 2017-03-22
• Results First Posted: 2017-05-02
• Last Update Posted: 2017-05-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 44456

Inclusion Criteria

• Patients undergoing routine MRI using the MRI contrast medium Dotarem

Exclusion Criteria

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
All included patients	MRI with Dotarem	All included patients underwent MRI with Dotarem

Primary Outcome Measures

Name	Time	Method
Frequency of Adverse Events	From the beginning of the MRI procedure to 30-60 min after	The frequency of adverse events (serious and non-serious) that occurred following injection of Dotarem was recorded.

Secondary Outcome Measures

Name	Time	Method
Diagnostic Value	During MRI procedure	Diagnostic value was evaluated by answering "yes" or "no" to the following question "Were you able to make a diagnosis based on the test results ?"
Image Quality	During MRI procedure	Image quality was evaluated with a 5-step scale from "excellent" to "very poor" ("excellent/very good"; "good"; "moderate"; "poor" and "very poor")