Risk of nephrogenic systemic fibrosis in patients with impaired renal function undergoing fixed-dose gadoxetic acid-enhanced magnetic resonance imaging

Purpose: To assess the risk of nephrogenic systemic fibrosis (NSF) in patients with renal impairment undergoing gadoxetic acid-enhanced magnetic resonance imaging. Methods: This retrospective study included patients who had an estimated glomerular filtration rate (eGFR) below 60 mL/min per 1.73 m² or had undergone dialysis around the time of gadoxetic acid exposure from January 2010 to November 2019. All patients received at least one intravenous injection of gadoxetic acid at a fixed dose of 2.5 mmol. The primary endpoint was the development of NSF after exposure to gadoxetic acid based on Girardi’s clinicopathological scoring system. Results: A total of 204 patients with renal impairment received 424 injections of gadoxetic acid, of which 131 and 54 had an eGFR of 30–59 and < 30 mL/min per 1.73 m², respectively, and 19 had undergone hemodialysis. Eighty-two patients received multiple injections, with 23 receiving five or more injections. The dose of each exposure ranged from 0.02 to 0.07 mmol/kg and the cumulative doses ranged from 0.02 to 0.45 mmol/kg. Thirty-three patients had concomitant Child–Pugh class B or C cirrhosis. No NSF was detected during follow-up (median 20 months; range 6 days to 111 months). The upper bound of the 95% confidence interval for NSF risk was 2.2% and 1.1% per patient and examination, respectively. Conclusion: No NSF was detected in this study. However, it is premature to ascertain the risk of NSF using gadoxetic acid in patients with renal impairment and further studies are warranted.