A DOUBLE-BLIND-STUDY TO EVALUATE THE TOLERABILITY OF GADODIAMIDE INJECTION AND ITS EFFECT ON RENAL-FUNCTION IN PATIENTS UNDERGOING CEREBRALMAGNETIC-RESONANCE-IMAGING

Gadodiamide injection was administered intravenously to 28 patients wi th cancer undergoing cerebral magnetic resonance imaging (MRI). Two pa rallel groups were used to evaluate the safety of single doses of 0.1 and 0.3 mmol per kilogram body weight (kgbw). Adverse events, vital si ps, blood chemistry, haematology and urinalysis were the principal mea sures of safety. Four patients, all in the 0.1 mmol kgbw-1 group, expe rienced a total of six adverse events. No adverse events were reported in the 0.3 mmol kgbw-1 group. No clinically significant changes in bl ood chemistry, haematology or urinalysis occurred. No significant chan ges in renal tubular function or glomerular filtration rate were obser ved after injection at either dose. Overall, this study suggests that gadodiamide injection is a safe and effective contrast medium for use in patients undergoing cerebral MRI at both the 0.1 and 0.3 mmol kgbw- 1 doses.