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

BACKGROUND: To date, few data on the safety profile of gadoterate meglumine in pediatric patients are available. PURPOSE: To 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 METHODS: The 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. RESULTS: The 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. CONCLUSION: This 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.