Post Marketing Surveillance Study for Evaluation of Efficacy and Safety of Dotarem in Magnetic Resonance Mammography

Completed

• Conditions: MR Mammography With Dotarem
• Interventions: Procedure: MR mammography with Dotarem

• Registration Number: NCT03041298
• 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) 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.

Detailed Description

Diagnostic efficacy was assessed on the basis of image quality (5-stage scale from "excellent" to "very poor"), diagnosis and cytology test result. Safety was assessed on the basis of the frequency and seriousness of adverse drug reactions observed following the injection of Dotarem.

Study Timeline

• Study Start: 2011-09
• Primary Completion: 2013-10
• Study Completion: 2013-12
• Study First Submitted: 2017-02-01
• Study First Submitted QC: 2017-02-01
• Study First Posted: 2017-02-02
• 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: 1537

Inclusion Criteria

• Patients who are scheduled for high-resolution MR mammography using the MRI contrast agent Dotarem

Exclusion Criteria

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
All included patients	MR mammography with Dotarem	All included patients underwent MR mammography with Dotarem

Primary Outcome Measures

Name	Time	Method
Image Quality	During MRI procedure	Image quality was evaluated on a 5-point scale: "excellent"; "good"; "moderate"; "poor" and "very poor".
Ability to Make a Diagnosis	During MRI procedure	Ability to make a diagnosis was evaluated by answering "yes" or "no" to the question "Did the examination permit a diagnosis ?"
Diagnostic Results (Percentage of Patients Per Diagnosis)	During MRI procedure	Diagnoses were made with MR images. Percentage of patients per diagnosis was calculated. Multiple diagnoses were possible for the same patient.
Cytology Test Results (Percentage of Patients Per Cytology Test Result)	During MRI procedure	Diagnoses were made according to the cytology test results. Percentage of patients per cytology test result was calculated. Multiple diagnoses were possible for the same patient.
Frequency of Adverse Drug Reactions	From the beginning of the MR mammography procedure to 30-60 min after	The frequency of adverse drug reactions (serious and non-serious) that occurred following injection of Dotarem was recorded. Adverse drug reactions are adverse events related to the product administered.