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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Evaluation of Efficacy and Safety of Dotarem in Magnetic Resonance Mammography

Conditions
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MR Mammography With Dotarem

Intervention / Treatment
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* Procedure: MR mammography with Dotarem


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

Ages Eligible for Study
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Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| All included patients<br>All included patients underwent MR mammography with Dotarem | Procedure: MR mammography with Dotarem<br> <br> * Other names: MR mammography with gadoteric acid/gadoterate meglumine;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Image Quality | Image quality was evaluated on a 5-point scale: excellent; good; moderate; poor and very poor. | 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 ? | 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. | 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. | 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. | From the beginning of the MR mammography procedure to 30-60 min after |