The safety and efficacy of neuroimaging with gadoversetamide injection in pediatric patients

ABSTRACTObjective: The safety and efficacy of gadoversetamide injection (OptiMARK) was examined in pediatric patients referred for magnetic resonance imaging (MRI) of the central nervous system (CNS). * OptiMARK is a registered trademark of Tyco Healthcare/Mallinckrodt, St. Louis, MO, USAResearch and design methods: This was an open-label, multicenter study in patients aged between 2 and 18 years scheduled for a contrastenhanced MRI study. Patients received a single injection of gadoversetamide (0.1 mmol/kg). Safety of gadoversetamide was evaluated by physical examinations and monitoring of adverse events, laboratory values, vital signs, and electrocardiogram readings before and after drug administration. Efficacy was assessed by three independent, blinded readers for confidence in diagnosis and level of conspicuity for lesion visualization on precontrast and postcontrast images. The diagnostic accuracy, sensitivity, and specificity of lesion detection were determined for the precontrast images, the postc...