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Research ArticlePatient Safety
Open Access

Nephrogenic Systemic Fibrosis Risk Assessment and Skin Biopsy Quantification in Patients with Renal Disease following Gadobenate Contrast Administration

E. Kanal, T.J. Patton, I. Krefting and C. Wang
American Journal of Neuroradiology March 2020, 41 (3) 393-399; DOI: https://doi.org/10.3174/ajnr.A6448
E. Kanal
aDepartments of Radiology (E.K.)
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T.J. Patton
bDermatology (T.J.P.), University of Pittsburgh Medical Center and University of Pittsburgh, Pittsburgh, Pennsylvania
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I. Krefting
cDivision of Medical Imaging and Radiation Medicine (I.K.)
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C. Wang
dOffice of Pharmacovigilance and Epidemiology (C.W.), US Food and Drug Administration, Silver Spring, Maryland.
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Abstract

BACKGROUND AND PURPOSE: Nephrogenic systemic fibrosis following administration of intravenous gadobenate during MR imaging is rare. This study aimed to analyze any nephrogenic systemic fibrosis–related risks and quantify skin gadolinium levels in patients with impaired renal function but without nephrogenic systemic fibrosis who had received gadobenate.

MATERIALS AND METHODS: In this retrospective study with a prospective skin biopsy phase, patients with estimated glomerular filtration rates of <60 mL/min/1.73 m2 undergoing contrast-enhanced MR imaging from July 2007 through June 2014 were screened for nephrogenic systemic fibrosis using a questionnaire. This was highly sensitive but not specific and reliably excluded nephrogenic systemic fibrosis if responses to at least 6 of the 8 questions were negative. If no nephrogenic systemic fibrosis was detected, a skin biopsy was requested.

RESULTS: Of 2914 patients who met these criteria, 1988 were excluded for various reasons. Of the remaining 926 patients, 860 were screened negative for nephrogenic systemic fibrosis. Of these, 17 (2%) had estimated glomerular filtration rates of <15 mL/min/1.73 m2, 51 (6%) had levels of 15 < 30 mL/min/1.73 m2, 234 (27%) had levels of 30 < 45 mL/min/1.73 m2, and 534 (62%) had levels of 45 < 60 mL/min/1.73 m2. Of the 66 who were not cleared of nephrogenic systemic fibrosis by the questionnaire, 6 patients were evaluated by a dermatologist and confirmed not to have nephrogenic systemic fibrosis (no biopsy required).

CONCLUSIONS: A diagnosis of nephrogenic systemic fibrosis was excluded in 860 patients with impaired renal function who were followed up and received gadobenate during MR imaging. In 14 such patients who underwent at least 1 gadobenate-enhanced MR imaging examination and did not have nephrogenic systemic fibrosis, gadolinium levels in the skin were exceedingly low.

ABBREVIATIONS:

eGFR
estimated glomerular filtration rate
GBCA
gadolinium-based contrast agents
ICP-MS
inductively coupled plasma mass spectrometry
NSF
nephrogenic systemic fibrosis
  • © 2020 by American Journal of Neuroradiology

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American Journal of Neuroradiology: 41 (3)
American Journal of Neuroradiology
Vol. 41, Issue 3
1 Mar 2020
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Cite this article
E. Kanal, T.J. Patton, I. Krefting, C. Wang
Nephrogenic Systemic Fibrosis Risk Assessment and Skin Biopsy Quantification in Patients with Renal Disease following Gadobenate Contrast Administration
American Journal of Neuroradiology Mar 2020, 41 (3) 393-399; DOI: 10.3174/ajnr.A6448

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Nephrogenic Systemic Fibrosis Risk Assessment and Skin Biopsy Quantification in Patients with Renal Disease following Gadobenate Contrast Administration
E. Kanal, T.J. Patton, I. Krefting, C. Wang
American Journal of Neuroradiology Mar 2020, 41 (3) 393-399; DOI: 10.3174/ajnr.A6448
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