Risk of nephrogenic systemic fibrosis (NSF) in oncology patients receiving gadoxetic acid and updated risk of estimate of NSF in patients receiving gadoxetic acid with moderate and severe renal impairment

Abstract

Objectives: Gadoxetic acid (GA) is a half-biliary excreted gadolinium-based contrast agent (GBCA) administered at lower dose than gadobenic acid with similar ionic structure. Gadobenic acid is considered low-risk for nephrogenic systemic fibrosis (NSF) in patients with impaired renal function; however, safety of GA is unclear. The objective of this study was to determine the incidence of NSF in oncology patients undergoing GA-enhanced MRI and to update the risk estimate of NSF in patients receiving GA with severe renal impairment.

Materials and methods: We retrospectively identified GA-enhanced MRI performed for treatment planning in confirmed cancer patients between March 2011 and December 2020. Serum creatinine values within 180 days of GA administration were retrieved and estimated glomerular filtration rate (eGFR) calculated. The eGFR value nearest to each MRI examination was used. The search result was linked to a prospectively maintained registry of reported cases of NSF. An updated literature review was conducted to identify published cases of NSF related to GA administration in patients with severe renal impairment (eGFR < 30 mL/min/1.73 m² or on dialysis) and the incidence of NSF with 95% confidence intervals (CI) was determined combining published data with our results.

Results: 192 oncology patients underwent GA-enhanced MRI, mean age was 65.6 ± 11.8 years with 73 women. The mean eGFR was 89.6 ± 33.0 mL/min/1.73 m². There were 33 patients with moderate (eGFR 30-60 mL/min/1.73 m²) and 1 patient with severe (eGFR < 30 mL/min/1.73 m²) renal impairment. There were no reported cases of NSF. Updated literature review including our results identified 340 patients with severe renal impairment or on dialysis with zero cases of NSF (0/340; 95% confidence intervals 0% and 0.9%).

Conclusion: No cases of NSF were documented in this study related to gadoxetic acid use in oncology patients, including those with moderate and severe renal impairment. Recent data indicate use of gadoxetic acid in patients with renal impairment can be considered low-risk.

Keywords: Gadolinium; Gadoxetic acid; MRI; Nephrogenic systemic fibrosis.