Diagnostic efficacy and safety of gadoteric acid MR mammography in 1537 patients. Issue 12 (December 2016)

• Record Type: Journal Article
• Authors: Seithe, Tim; Braun, Joachim; Wolf, Michael; Vahldiek, Janis; Wolny, Dajana; Auer, Jonas; Pociej, Joanna; Heine, Oliver; Hamm, Bernd; de Bucourt, Maximilian
• Is Part Of: European journal of radiology. Volume 85:Issue 12(2016)
• Page Start: 2281
• Page End: 2287
• Publication Date: 2016-12
• Subjects: MR mammography -- Gadoteric acid -- Gadoterate meglumine -- Post-marketing surveillance -- Efficacy -- Adverse drug reactions; Medical radiology -- Periodicals; Radiology -- Periodicals; Radiologie médicale -- Périodiques; Medical radiology; Periodicals; 616.075705
• DOI: 10.1016/j.ejrad.2016.10.013
• Languages: English
• ISSNs: 0720-048X

Abstract

Abstract: Objectives: To perform a large-scale multicenter post-marketing surveillance study for analyzing diagnostic effectiveness and safety of intravenous (IV) gadoteric acid (Dotarem ® ) in magnetic resonance (MR) mammography under daily practice conditions. Materials and methods: Patients underwent high-resolution MR mammography with gadoteric acid in 15 German centers. Radiologists used a standardized questionnaire to report data including patient demographics and medical history, characteristics of MR examination and results in terms of diagnosis and safety for the patient. Results: A total of 1537 patients were examined. In 99.2% of all patients, a diagnosis was established. In 91.6% of all patients, image quality was excellent or good. Histopathological examinations were performed for 232 of 1537 patients (15.1%) with invasive ductal carcinoma being the most frequent diagnosis (109 patients, 47.0%). Based on histopathology as the standard of reference, IV gadoteric acid-enhanced MR mammography confirmed diagnoses of invasive ductal carcinoma in 93.5% of the patients. Adverse drug reactions occurred in 5 of 1537 patients (0.3%) and were classified as serious in one case (tachycardia, dysphagia, urticaria, rash). All patients with adverse drug reactions fully recovered after the examination. Conclusion: This noninterventional surveillance study shows IV gadoteric acid to be a safe and effective contrast agent for use in MR mammography.