Gadodiamide injection at 0.1 and 0.3 mmol/kg body weight: a phase III double-blind, parallel, randomised clinical investigation of known or suspected central nervous system lesions at 1.5 T.

We studied 78 patients with clinically suspected central nervous system abnormalities (66 intracranial, 12 spinal) by MRI before and after administration of the nonionic contrast medium gadodiamide injection. A parallel, double-blind, randomised design was followed. Two dosages were used: 38 patients underwent studies with 0.1 mmol/kg body weight (b.w.) and 40 with 0.3 mmol/kg b.w. MRI showed abnormalities in 36 of the 38 patients receiving the lower dose and 39 of the 40 patients receiving the higher dose. In 3 patients from each group more lesions were seen following injection than before. The contrast medium improved the delineation of abnormal structures and assessment of tumour size and increased their signal intensity indices in both groups, but especially at the higher dose. Administration of gadodiamide injection provided more diagnostic information in about 75% of the patients, independently of the dose. There were no reports of discomfort, but 7 patients reported adverse events considered unrelated to the gadodiamide injection. The two doses were found to be equally safe and efficient for diagnosis.