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Abstract #1273

Multinational Phase III Clinical Trial of the Safety and Efficacy of Gadobenate Dimeglumine for Contrast-Enhanced MR Neuroimaging in Children

Matthew J. Kuhn1, Emilio Cianciulli2, Claudio Fonda3, Mieczyslaw Pasowicz4, Pei-yi Gao5

1Radiology, Southern Illinois University School of Medicine, Springfield, IL, USA; 2Radiology, Santobono Pausillipon Childrens Hospital, Naples, Italy; 3Radiodiagnostics Unit, Anna Meyer Pediatric Hospital, Florence, Italy; 4Radiology, Krakow Hospital John Paul II, Krakow, Poland; 5Radiology, Beijing Tian Tan Hospital, Beijing, China

92 children were enrolled in a multinational clinical trial of 0.1 mmol/kg gadobenate dimeglumine for MRI of the CNS. Nine non serious, mild to moderate adverse events were reported in 8 children (8.7%). Headache was reported in 2 patients with all other reported AE occurring once. According to 3 blinded readers gadobenate dimeglumine provided additional diagnostic information over predose images in 83.7-96.7% of patients. Quantitative assessments showed significantly greater LBR (p<0.0001) and CNR (p<0.0016) after gadobenate dimeglumine. At a dose of 0.1 mmol/kg, gadobenate dimeglumine is a safe and efficacious for contrast-enhanced MRI of CNS lesions in children.