Gadobutrol in Renally Impaired Patients

Abstract

ObjectiveThe aim of this study was to assess the potential risk of gadobutrol-enhanced magnetic resonance imaging (MRI) in patients with moderate to severe renal impairment for the development of nephrogenic systemic fibrosis (NSF).Materials and MethodsWe performed a prospective, international, multicenter, open-label study in 55 centers. Patients with moderate to severe renal impairment scheduled for any gadobutrol-enhanced MRI were included. All patients received a single intravenous bolus injection of gadobutrol at a dose of 0.1 mmol/kg body weight. The primary target variable was the number of patients who develop NSF within a 2-year follow-up period.ResultsA total of 908 patients were enrolled, including 586 with moderate and 284 with severe renal impairment who are at highest risk for developing NSF. The mean time since renal disease diagnosis was 1.83 and 5.49 years in the moderate and severe renal impairment cohort, respectively. Overall, 184 patients (20.3%) underwent further contrast-enhanced MRI with other gadolinium-based contrast agents within the 2-year follow-up. No patient developed symptoms conclusive of NSF.ConclusionsNo safety concerns with gadobutrol in patients with moderate to severe renal impairment were identified. There were no NSF cases.

Abbreviated‐protocol screening MRI vs. complete‐protocol diagnostic MRI for detection of hepatocellular carcinoma in patients with cirrhosis: An equivalence study using LI‐RADS v2018

“…Moreover, MRI scanner accessibility and radiology expertise may influence the broad adoption of screening MRI to replace ultrasound. Finally, we did not evaluate potential safety issues related to repeated administration of GBCA for HCC surveillance, although recent studies have shown the safety of macrocyclic agents even in patients with impaired renal function . While further research is needed to ascertain any adverse effect of macrocyclic GBCA, HCC screening remains a high priority for cirrhosis patients, as HCC is the leading cause of death among cirrhosis patients.…”

“…Finally, we did not evaluate potential safety issues related to repeated administration of GBCA for HCC surveillance, although recent studies have shown the safety of macrocyclic agents even in patients with impaired renal function. 44 While further research is needed to ascertain any adverse effect of macrocyclic GBCA, HCC screening remains a high priority for cirrhosis patients, as HCC is the leading cause of death among cirrhosis patients. Meanwhile, trials assessing the potential feasibility of annual noncontrast MRI in comparison with traditional ultrasound screening are currently ongoing.…”

Gadolinium‐based contrast agents: A comprehensive risk assessment

“…Changes in practice patterns, such as routine screening for renal insufficiency, withholding GBCAs in patients in advanced CKD, and a widespread shift away from the high‐risk GBCAs (ie, gadopentetate [Magnevist], gadodiamide [Omniscan], and gadoversetamide [OptiMARK]) have almost completely eliminated new cases of NSF. At least six prospective trials involving more than 2200 patients have been conducted to assess the risk of NSF in patients with renal impairment receiving GBCAs . Nearly half of the patients in these trials had eGFRs <30 mL/min/1.73‐m 2 , and one study included 268 patients on dialysis .…”

“…At least six prospective trials involving more than 2200 patients have been conducted to assess the risk of NSF in patients with renal impairment receiving GBCAs. 21,[89][90][91][92][93] Nearly half of the patients in these trials had eGFRs <30 mL/min/1.73m 2 , and one study included 268 patients on dialysis. 89 These studies tested all GBCAs except the three agents (ie, the high-risk agents listed above) with the strongest associations with NSF.…”

Clinical application and technical considerations of T 1 & T 2(*) mapping in cardiac, liver, and renal imaging

“…The administration of contrast in patients with severely impaired renal function is controversial due to the risk of nephrogenic systemic fibrosis, 78 however, new insights suggest that modern macrocyclic GBCAs may not be associated with the development of nephrogenic systemic fibrosis even when administered to high risk chronic kidney disease patients. [79][80][81][82] Renal T 2 mapping has thus far only been evaluated in mouse models, which showed that renal cortex T 2 values increase after kidney transplantation 73 and that renal T 2 is highly correlated with the histological cystic index in a polycystic kidney disease model. 83 Further research is needed to assess whether T 2 mapping could be useful for assessment of edema, or for the prediction of cyst progression in humans.…”