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

Guerbet1,537 enrolled

Overview

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.

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 Type

OBSERVATIONAL

Enrollment

1,537

Conditions

MR Mammography With Dotarem

Interventions

MR mammography with DotaremPROCEDURE

Eligibility

Sex: ALLMax age: 100 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Patients who are scheduled for high-resolution MR mammography using the MRI contrast agent Dotarem Exclusion Criteria: \-

Outcomes

Primary Outcomes

Image Quality

Image quality was evaluated on a 5-point scale: "excellent"; "good"; "moderate"; "poor" and "very poor".

Time frame: During MRI procedure

Ability to Make a Diagnosis

Ability to make a diagnosis was evaluated by answering "yes" or "no" to the question "Did the examination permit a diagnosis ?"

Time frame: During MRI procedure

Diagnostic Results (Percentage of Patients Per Diagnosis)

Diagnoses were made with MR images. Percentage of patients per diagnosis was calculated. Multiple diagnoses were possible for the same patient.

Time frame: During MRI procedure

Cytology Test Results (Percentage of Patients Per Cytology Test Result)

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.

Time frame: During MRI procedure

Frequency of Adverse Drug Reactions

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.

Time frame: From the beginning of the MR mammography procedure to 30-60 min after

Data from ClinicalTrials.gov

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