CLINICAL-EVALUATION OF GADODIAMIDE INJECTION IN PEDIATRIC MR-IMAGING

The safety and efficacy of intravenous gadodiamide injection, 0.1 mmol /kg body weight, have been evaluated in an open label, noncomparative as to drug, phase III clinical trial in 50 children from 6 months to 1 3 years of age, referred for MRI requiring the injection of a contrast medium, The central nervous system and other body areas were examined with T1 sequences before and after intravenous injection of the contr ast medium. Overall safety was very good and no clinically relevant ch anges were evident as regards heart rate and venous blood oxygen satur ation after injection, No adverse event or discomfort was experienced by conscious patients that could with certainty be related to the cont rast medium, but slight movements were observed in two sedated patient s that could be related to the injection. Comparing pre- and post-inje ction images, additional diagnostic information could be obtained from the latter in 41 patients (82 %). In these images, the number of lesi ons detected increased and they were generally better delineated and t heir size more easily estimated, The results of this trial indicate th at gadodiamide injection is safe and effective for MRI examinations in children.