Safety of gadoterate meglumine in over 1600 children included in the prospective observational SECURE study.

Abstract

BackgroundTo date, few data on the safety profile of gadoterate meglumine in pediatric patients are available.PurposeTo assess the safety profile of gadoterate meglumine in routine practice, to detect any case of nephrogenic systemic fibrosis (NSF) suspicion and to collect efficacy data.Material and MethodsThe pediatric population of the observational SECURE study comprised 1631 patients scheduled for contrast-enhanced magnetic resonance imaging (MRI) with gadoterate meglumine (dose: 0.1 mmol/kg). Risk factors, MRI types and immediate adverse events (AEs) were systematically recorded. Patients with moderate to severe renal impairment were followed up for at least 3 months for detection of any NSF suspicion. Efficacy was assessed by the on-site radiologist in terms of image quality and ability to come to diagnosis.ResultsThe population included 106 children (6.5%) aged <2 years, 815 (50.0%) aged 2 to <12 years and 710 (43.5%) aged 12 to <18 years, with a mean (± SD) age of 10.2 (± 4.9) years. Central nervous system exploration was the most frequent MRI type (80.4%) and main risk factors were any stage of renal insufficiency (9.8%) and allergies (5.2%). Only one AE (vomiting) that was deemed doubtfully related to gadoterate meglumine was observed. No suspicions of NSF were reported. Good to very good image quality was obtained for 98.4% of pediatric patients and diagnosis was established in 99.6% of cases.ConclusionThis study confirmed the good safety profile of gadoterate meglumine in routine practice in a large pediatric population. The study is registered on https://clinicaltrials.gov/ with the identifier NCT01523873.