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Diagnostic efficacy and safety of gadoteric acid MR mammography in 1537 patients.
- Source :
-
European journal of radiology [Eur J Radiol] 2016 Dec; Vol. 85 (12), pp. 2281-2287. Date of Electronic Publication: 2016 Oct 14. - Publication Year :
- 2016
-
Abstract
- Objectives: To perform a large-scale multicenter post-marketing surveillance study for analyzing diagnostic effectiveness and safety of intravenous (IV) gadoteric acid (Dotarem <superscript>®</superscript> ) in magnetic resonance (MR) mammography under daily practice conditions.<br />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.<br />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.<br />Conclusion: This noninterventional surveillance study shows IV gadoteric acid to be a safe and effective contrast agent for use in MR mammography.<br /> (Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.)
- Subjects :
- Administration, Intravenous
Adolescent
Adult
Aged
Aged, 80 and over
Breast Neoplasms diagnostic imaging
Carcinoma, Ductal, Breast diagnostic imaging
Deglutition Disorders chemically induced
Early Detection of Cancer
Exanthema chemically induced
Female
Humans
Image Enhancement methods
Male
Middle Aged
Product Surveillance, Postmarketing
Safety
Tachycardia chemically induced
Urticaria chemically induced
Young Adult
Breast diagnostic imaging
Contrast Media administration & dosage
Contrast Media adverse effects
Magnetic Resonance Imaging methods
Meglumine administration & dosage
Meglumine adverse effects
Organometallic Compounds administration & dosage
Organometallic Compounds adverse effects
Subjects
Details
- Language :
- English
- ISSN :
- 1872-7727
- Volume :
- 85
- Issue :
- 12
- Database :
- MEDLINE
- Journal :
- European journal of radiology
- Publication Type :
- Academic Journal
- Accession number :
- 27842678
- Full Text :
- https://doi.org/10.1016/j.ejrad.2016.10.013