Post Marketing Surveillance Study for Evaluation of Efficacy and Safety of Dotarem in Magnetic Resonance Mammography
|ClinicalTrials.gov Identifier: NCT03041298|
Recruitment Status : Completed
First Posted : February 2, 2017
Results First Posted : May 2, 2017
Last Update Posted : May 2, 2017
Information provided by (Responsible Party):
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.
|Condition or disease||Intervention/treatment|
|MR Mammography With Dotarem||Procedure: MR mammography with Dotarem|
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|
|Actual Enrollment :||1537 participants|
|Official Title:||Evaluation of Efficacy and Safety of Dotarem in Magnetic Resonance Mammography|
|Study Start Date :||September 2011|
|Actual Primary Completion Date :||October 2013|
|Actual Study Completion Date :||December 2013|
All included patients
All included patients underwent MR mammography with Dotarem
Procedure: MR mammography with Dotarem
Other Name: MR mammography with gadoteric acid/gadoterate meglumine
Primary Outcome Measures :
- Image Quality [ Time Frame: During MRI procedure ]Image quality was evaluated on a 5-point scale: "excellent"; "good"; "moderate"; "poor" and "very poor".
- Ability to Make a Diagnosis [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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 [ Time Frame: 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.
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