COMPARISON OF THE SAFETY OF STANDARD AND TRIPLE DOSE GADODIAMIDE INJECTION IN MR-IMAGING OF THE CENTRAL-NERVOUS-SYSTEM - A DOUBLE-BLIND-STUDY

Gadodiamide injection was administered intravenously to 49 patients wi th known or suspected CNS lesions undergoing MR imaging. Two parallel groups were used to evaluate the efficacy and safety of single doses o f 0.1 (25 patients) and 0.3 (24 patients) mmol/kg b.w. The principal m easures of efficacy were diagnostic yield of MR and the overall contra st enhancement. Adverse events and serum bilirubin were the main safet y parameters. Contrast enhancement of the lesion was observed for 16 p atients in each dose group. Thirteen patients in the 0.1 and 17 in the 0.3 mmol/kg group had their diagnosis amended following the postcontr ast image, but only one patient in each dose group had their managemen t affected by new information from the postcontrast image. The overall diagnostic utility of gadodiamide injection was good, but there were no differences between the 2 doses studied in this respect. No injecti on-associated discomfort or other adverse events were reported. No cli nically important changes in serum bilirubin, or other parameters of b lood chemistry, or hematology were observed. Overall, the safety profi le of gadodiamide injection 0.3 mmol/kg b.w. in this study was similar to that of 0.1 mmol/kg b.w.