Nephrogenic systemic fibrosis risk after liver magnetic resonance imaging with gadoxetate disodium in patients with moderate to severe renal impairment: results of a prospective, open-label, multicenter study

Investigative Radiology
Thomas LauensteinJan Endrikat

Abstract

The objective of this study was to assess the risk of gadoxetate disodium in liver imaging for the development of nephrogenic systemic fibrosis (NSF) in patients with moderate to severe renal impairment. We performed a prospective, multicenter, nonrandomized, open-label phase 4 study in 35 centers from May 2009 to July 2013. The study population consisted of patients with moderate to severe renal impairment scheduled for liver imaging with gadoxetate disodium. All patients received a single intravenous bolus injection of 0.025-mmol/kg body weight of liver-specific gadoxetate disodium. The primary target variable was the number of patients who develop NSF within a 2-year follow-up period. A total of 357 patients were included, with 85 patients with severe and 193 patients with moderate renal impairment, which were the clinically most relevant groups. The mean time period from diagnosis of renal disease to liver magnetic resonance imaging (MRI) was 1.53 and 5.46 years in the moderate and severe renal impairment cohort, respectively. Overall, 101 patients (28%) underwent additional contrast-enhanced MRI with other gadolinium-based MRI contrast agents within 12 months before the start of the study or in the follow-up. No patient de...Continue Reading

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Citations

Jan 14, 2017·Journal of Magnetic Resonance Imaging : JMRI·Tyler J FraumKathryn J Fowler
May 1, 2018·Canadian Association of Radiologists Journal = Journal L'Association Canadienne Des Radiologistes·Nicola SchiedaSwapnil Hiremath
Jul 2, 2016·Topics in Magnetic Resonance Imaging : TMRI·Reza Forghani
Jun 23, 2020·Annals of Internal Medicine·Joseph LunyeraKaren M Goldstein
Aug 17, 2016·Investigative Radiology·Henrik J MichaelyJan Endrikat
Sep 30, 2020·Radiology·Jitka StarekovaScott B Reeder
Sep 4, 2015·Advanced Healthcare Materials·Lucas W E StarmansHolger Grüll
Apr 15, 2017·Pediatric Radiology·Eric M GaleMichael S Gee
Jul 16, 2020·Abdominal Radiology·Eliane Donato Leite ParoSuzan Menasce Goldman
Dec 16, 2018·European Radiology·Yang Shin ParkChang Hee Lee
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Apr 5, 2021·Journal of Neuro-ophthalmology : the Official Journal of the North American Neuro-Ophthalmology Society·Victoria SattarovaCollin M McClelland
Aug 28, 2021·Journal of the Formosan Medical Association = Taiwan Yi Zhi·Shao-Yu YangHeng-Chih Pan

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Methods Mentioned

BETA
biopsy

Clinical Trials Mentioned

NCT00908596

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