Safety and efficacy of gadobutrol-enhanced MRI in patients aged under 2 years-a single-center, observational study.

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.