ESTIMATION OF RISK OF NEPHROGENIC SYSTEMIC FIBROSIS IN PATIENTS OF STAGE 3-5 CHRONIC KIDNEY DISEASE UNDERGOING MAGNETIC RESONANCE IMAGING WITH INJECTABLE GADOBUTROL

Abstract

Background: Nephrogenic systemic fibrosis is a rare but serious fibrosing disorder associated with gadolinium-based contrast agents, particularly in patients with impaired renal function. Newer macrocyclic agents such as gadobutrol have greater chelate stability and are considered to have a very low risk of nephrogenic systemic fibrosis. However, local clinical data in patients with stage 3–5 chronic kidney disease remain limited, making post-contrast safety assessment important for practical radiology decision-making.

Objective: To determine the frequency of nephrogenic systemic fibrosis among patients with stage 3–5 chronic kidney disease undergoing contrast-enhanced magnetic resonance imaging with injectable gadobutrol.

Methods: This prospective descriptive follow-up study was conducted in the Department of Diagnostic Radiology, Doctors Hospital and Medical Center, Lahore, from September 2025 to April 2026, after approval from the College of Physicians and Surgeons Pakistan. A total of 101 patients aged 20–80 years with estimated glomerular filtration rate below 60 mL/min/1.73 m² were enrolled through non-probability consecutive sampling. All patients underwent contrast-enhanced magnetic resonance imaging with intravenous gadobutrol at a standard dose of 0.1 mmol/kg. Immediate adverse reactions were observed for one hour after contrast administration. Clinical follow-up was performed at 1, 3, and 6 months to assess symptoms suggestive of nephrogenic systemic fibrosis. Data were analyzed using SPSS, and a p-value <0.05 was considered statistically significant.

Results: Of 101 patients, 59 were male (58.4%) and 42 were female (41.6%). The mean age was 61.4 ± 10.8 years. Stage 3, stage 4, and stage 5 chronic kidney disease were present in 49 (48.5%), 36 (35.6%), and 16 (15.8%) patients, respectively. Diabetes mellitus was present in 74 patients (73.3%), hypertension in 89 (88.1%), and 15 (14.9%) were on dialysis. Follow-up was completed in 95 patients (94.1%). No patient developed clinical features suggestive of nephrogenic systemic fibrosis. Mild transient adverse reactions occurred in 3 patients (3.0%), while no moderate or severe reaction was recorded.

Conclusion: No case of nephrogenic systemic fibrosis was observed after standard-dose gadobutrol-enhanced magnetic resonance imaging in patients with stage 3–5 chronic kidney disease during the follow-up period. These findings support the low observed clinical risk of gadobutrol in renal impairment, although larger multicenter studies with longer follow-up are needed.