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

Guerbet

Status: Completed

Conditions: MR Mammography With Dotarem

Treatments: Procedure: MR mammography with Dotarem

Study type: Observational

Funder types: Industry

Identifiers

NCT03041298

DGD-55-006

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,537 patients

Sex: All

Ages: Under 100 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

Trial design

1,537 participants in 1 patient group

All included patients

Description:

All included patients underwent MR mammography with Dotarem

Treatment:

Procedure: MR mammography with Dotarem