OBJECTIVE: The purpose of this study was to assess the diagnostic value and safety of the contrast agent gadoterate meglumine (Gd-DOTA, DOTAREM, Guerbet, Roissy CdG Cedex, France) in the setting of a postmarketing surveillance study. MATERIALS AND METHODS: Between January 2004 and October 2005, radiologists in 61 radiologic institutions were asked to document the routine use of Gd-DOTA in a questionnaire. In addition to assessing the image quality and diagnostic value of the contrast-enhanced magnetic resonance imaging scans, we statistically evaluated and analyzed demographic and safety data. RESULTS: A total of 24,308 patients were intravenously injected with Gd-DOTA for various diagnostic examinations. The examination allowed for establishing a diagnosis in >99% of cases and image quality was rated as "excellent" or "good" in 97.5% of all cases. Adverse events were noted in only 0.4% of the examinations and were mostly rated as minor, such as feeling of warmth or taste alteration. There was one serious adverse event, albeit with complete recovery. CONCLUSION: This postmarketing surveillance study suggests diagnostic efficacy and a favorable clinical safety profile of Gd-DOTA in clinical practice.
OBJECTIVE: The purpose of this study was to assess the diagnostic value and safety of the contrast agent gadoterate meglumine (Gd-DOTA, DOTAREM, Guerbet, Roissy CdG Cedex, France) in the setting of a postmarketing surveillance study. MATERIALS AND METHODS: Between January 2004 and October 2005, radiologists in 61 radiologic institutions were asked to document the routine use of Gd-DOTA in a questionnaire. In addition to assessing the image quality and diagnostic value of the contrast-enhanced magnetic resonance imaging scans, we statistically evaluated and analyzed demographic and safety data. RESULTS: A total of 24,308 patients were intravenously injected with Gd-DOTA for various diagnostic examinations. The examination allowed for establishing a diagnosis in >99% of cases and image quality was rated as "excellent" or "good" in 97.5% of all cases. Adverse events were noted in only 0.4% of the examinations and were mostly rated as minor, such as feeling of warmth or taste alteration. There was one serious adverse event, albeit with complete recovery. CONCLUSION: This postmarketing surveillance study suggests diagnostic efficacy and a favorable clinical safety profile of Gd-DOTA in clinical practice.
Authors: M Essig; N Anzalone; S E Combs; À Dörfler; S-K Lee; P Picozzi; A Rovira; M Weller; M Law Journal: AJNR Am J Neuroradiol Date: 2011-10-20 Impact factor: 3.825
Authors: Anu Autio; Antti Saraste; Nobuyuki Kudomi; Tiina Saanijoki; Jarkko Johansson; Heidi Liljenbäck; Miikka Tarkia; Vesa Oikonen; Hannu T Sipilä; Anne Roivainen Journal: Am J Nucl Med Mol Imaging Date: 2014-09-06
Authors: Howard H Chen; Philip A Waghorn; Lan Wei; Luis F Tapias; Daniel T Schühle; Nicholas J Rotile; Chloe M Jones; Richard J Looby; Gaofeng Zhao; Justin M Elliott; Clemens K Probst; Mari Mino-Kenudson; Gregory Y Lauwers; Andrew M Tager; Kenneth K Tanabe; Michael Lanuti; Bryan C Fuchs; Peter Caravan Journal: JCI Insight Date: 2017-06-02
Authors: Alexis Jacquier; Matthew Bucknor; Loi Do; Philippe Robert; Claire Corot; Charles B Higgins; Maythem Saeed Journal: MAGMA Date: 2008-04-30 Impact factor: 2.310