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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.

Publication ,  Journal Article
Lauenstein, T; Ramirez-Garrido, F; Kim, YH; Rha, SE; Ricke, J; Phongkitkarun, S; Boettcher, J; Gupta, RT; Korpraphong, P; Tanomkiat, W; Liu, PS ...
Published in: Invest Radiol
June 2015

OBJECTIVE: 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. MATERIALS AND METHODS: 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. RESULTS: 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 developed symptoms conclusive of NSF within the 2-year follow-up. CONCLUSIONS: Gadoxetate disodium in patients with moderate to severe renal impairment did not raise any clinically significant safety concern. No NSF cases were observed.

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Published In

Invest Radiol

DOI

EISSN

1536-0210

Publication Date

June 2015

Volume

50

Issue

6

Start / End Page

416 / 422

Location

United States

Related Subject Headings

  • Young Adult
  • Severity of Illness Index
  • Risk
  • Prospective Studies
  • Nuclear Medicine & Medical Imaging
  • Nephrogenic Fibrosing Dermopathy
  • Middle Aged
  • Male
  • Magnetic Resonance Imaging
  • Liver
 

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Lauenstein, T., Ramirez-Garrido, F., Kim, Y. H., Rha, S. E., Ricke, J., Phongkitkarun, S., … Endrikat, J. (2015). 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. Invest Radiol, 50(6), 416–422. https://doi.org/10.1097/RLI.0000000000000145
Lauenstein, Thomas, Francisco Ramirez-Garrido, Young Hoon Kim, Sung Eun Rha, Jens Ricke, Sith Phongkitkarun, Joachim Boettcher, et al. “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.Invest Radiol 50, no. 6 (June 2015): 416–22. https://doi.org/10.1097/RLI.0000000000000145.
Lauenstein T, Ramirez-Garrido F, Kim YH, Rha SE, Ricke J, Phongkitkarun S, Boettcher J, Gupta RT, Korpraphong P, Tanomkiat W, Furtner J, Liu PS, Henry M, Endrikat J. 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. Invest Radiol. 2015 Jun;50(6):416–422.

Published In

Invest Radiol

DOI

EISSN

1536-0210

Publication Date

June 2015

Volume

50

Issue

6

Start / End Page

416 / 422

Location

United States

Related Subject Headings

  • Young Adult
  • Severity of Illness Index
  • Risk
  • Prospective Studies
  • Nuclear Medicine & Medical Imaging
  • Nephrogenic Fibrosing Dermopathy
  • Middle Aged
  • Male
  • Magnetic Resonance Imaging
  • Liver