title: Safety and efficacy of gadobutrol-enhanced MRI in patients aged under 2 years-a single-center, observational study.
abstract: Gadobutrol is a 1-molar gadolinium-based contrast agent with well-characterized safety and efficacy for magnetic resonance imaging (MRI) in adults and children ≥ 2 years old. This observational study assessed gadobutrol-enhanced MRI in children < 2 years of age. Sixty infants (mean age 11.1 months) underwent MRI using gadobutrol at standard dose of 0.1 mL/kg (0.1 mmol/kg) body weight. MRI examinations included brain, spine, and neck (n = 24), subcutaneous soft tissues (n = 14), chest, abdomen, and pelvis (n = 12), musculoskeletal system (n = 7) and vascular system (n = 3). No patients experienced adverse events related to gadobutrol injection. In 57 patients with confirmed diagnoses, gadobutrol-enhanced MRI provided findings consistent with confirmed pathologies. This study indicates that gadobutrol at a standard dose for MRI is safe in patients aged < 2 years and provides diagnostic information for multiple pathologies.
authors.affiliation: Department of Radiology and Diagnostic Imaging, Stollery Children's Hospital, University of Alberta, Edmonton, Alberta, Canada.
authors.forename: Ravi
authors.initials: R
authors.lastname: Bhargava
authors.affiliation: Department of Radiology and Diagnostic Imaging, Stollery Children's Hospital, University of Alberta, Edmonton, Alberta, Canada.
authors.forename: Michelle
authors.initials: M
authors.lastname: Noga
keywords: contrast media; gadobutrol; gadolinium; pediatric MRI
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