title: Diagnostic efficacy and safety of gadoteric acid MR mammography in 1537 patients.
abstract: OBJECTIVE
  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.
  
  
  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.
  
  
  CONCLUSIONS
  This noninterventional surveillance study shows IV gadoteric acid to be a safe and effective contrast agent for use in MR mammography.
authors.affiliation: Department of Radiology, Charité - University Medicine, Berlin, Germany.
authors.forename: Tim
authors.initials: T
authors.lastname: Seithe
authors.affiliation: Department of Radiology, Charité - University Medicine, Berlin, Germany.
authors.forename: Joachim
authors.initials: J
authors.lastname: Braun
authors.affiliation: Michael Wolf Information Systems, Viktoriastr. 26, 66346 Püttlingen, Germany.
authors.forename: Michael
authors.initials: M
authors.lastname: Wolf
authors.affiliation: Department of Radiology, Charité - University Medicine, Berlin, Germany.
authors.forename: Janis
authors.initials: J
authors.lastname: Vahldiek
authors.affiliation: Department of Radiology, Charité - University Medicine, Berlin, Germany.
authors.forename: Dajana
authors.initials: D
authors.lastname: Wolny
authors.affiliation: Department of Radiology, Charité - University Medicine, Berlin, Germany.
authors.forename: Jonas
authors.initials: J
authors.lastname: Auer
authors.affiliation: Department of Radiology, Charité - University Medicine, Berlin, Germany.
authors.forename: Joanna
authors.initials: J
authors.lastname: Pociej
authors.affiliation: Guerbet GmbH, Otto-Vogler-Str. 11, 65843 Sulzbach, Germany.
authors.forename: Oliver
authors.initials: O
authors.lastname: Heine
authors.affiliation: Department of Radiology, Charité - University Medicine, Berlin, Germany.
authors.forename: Bernd
authors.initials: B
authors.lastname: Hamm
authors.affiliation: Department of Radiology, Charité - University Medicine, Berlin, Germany. Electronic address: mdb@charite.de.
authors.forename: Maximilian
authors.initials: M
authors.lastname: de Bucourt
mesh_terms: D061605:Administration, Intravenous; D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001940:Breast / Q000000981:diagnostic imaging*; D001943:Breast Neoplasms / Q000000981:diagnostic imaging; D018270:Carcinoma, Ductal, Breast / Q000000981:diagnostic imaging; D003287:Contrast Media / Q000008:administration & dosage / Q000009:adverse effects; D003680:Deglutition Disorders / Q000139:chemically induced; D055088:Early Detection of Cancer; D005076:Exanthema / Q000139:chemically induced; D005260:Female; D006801:Humans; D007089:Image Enhancement / Q000379:methods; D008279:Magnetic Resonance Imaging / Q000379:methods*; D008297:Male; D008536:Meglumine / Q000008:administration & dosage / Q000009:adverse effects; D008875:Middle Aged; D009942:Organometallic Compounds / Q000008:administration & dosage / Q000009:adverse effects; D011358:Product Surveillance, Postmarketing; D012449:Safety; D013610:Tachycardia / Q000139:chemically induced; D014581:Urticaria / Q000139:chemically induced; D055815:Young Adult
chemical_list: D003287:Contrast Media; D009942:Organometallic Compounds; D008536:Meglumine; C072417:gadoterate meglumine
keywords: Adverse drug reactions; Efficacy; Gadoterate meglumine; Gadoteric acid; MR mammography; Post-marketing surveillance