Gadodiamide injection at two dose levels in MRI of CNS lesions: a phase-III study

A double-blind, randomized, parallel study was conducted to evaluate the safety and diagnostic utility of gadodiamide injection (a nonionic chelate of gadolinium and diethylenetriamine pentaacetic acid bis-(methylamide) [Gd-DTPA-BMA]) when administered IV for MRI of the central nervous system (CNS) at doses of 0.1 mmol/kg body weight (b.w.) or 0.3 mmol/kg b.w. A total of 24 patients received the lower dose and 23 the higher dose. Gadodiamide injection was administered to patients referred for MRI due to known or suspected CNS lesions. No clinically significant difference in blood parameters or efficacy was found between the two groups. The number of patients with adverse events other than discomfort was higher in the 0.3 group compared with the 0.1 group. In the 0.1 group, none of the 24 patients experienced any adverse events other than discomfort, and in the 0.3 group, 5 of 23 patients (21.7 %) experienced a total of five adverse events other than discomfort. All adverse events were of mild or moderate intensity. Postinjection MR scans provided new information that affected patient management in the case of 6 patients in the 0.1 group and 9 in the 0.3 group. (orig.)