Objective: 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).
Research and design methods: This was an open-label, multicenter study in patients aged between 2 and 18 years scheduled for a contrast-enhanced 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 postcontrast images, and the precontrast and postcontrast images read together.
Results: No drug-related moderate or serious adverse events were observed in this study, according to site investigators. A total of four adverse events in four of 100 patients (4%) were deemed likely related to gadoversetamide injection by the site investigators. All were mild in severity and not clinically significant. The most common adverse events, regardless of relationship to study drug, were injection-site reactions and a small prolongation of the QT interval. The administration of gadoversetamide significantly increased the level of lesion conspicuity and diagnostic confidence (p < 0.05). Compared with the nonenhanced image, gadoversetamide significantly increased the accuracy and sensitivity of lesion detection (p < 0.05). Limitations of the study included a lack of physiological measurements after sedation and prior to contrast administration, a single dose of gadoversetamide administered (0.1 mmol/kg) and patients younger than 2 years of age were excluded.
Conclusion: The administration of gadoversetamide injection (0.1 mmol/kg) was safe, well tolerated and produced clinically appropriate contrast enhancement for MRI of the CNS in the pediatric population.