GADODIAMIDE INJECTION AT 0.1-MMOL KG AND 0.3-MMOL/KG BODY-WEIGHT - A PHASE-III DOUBLE-BLIND, PARALLEL, RANDOMIZED CLINICAL INVESTIGATION OFKNOWN OR SUSPECTED CENTRAL-NERVOUS-SYSTEM LESIONS AT 1.5-T/

We studied 78 patients with clinically suspected central nervous syste m abnormalities (66 intracranial, 12 spinal) by MRI before and after a dministration of the nonionic contrast medium gadodiamide injection. A parallel, double-blind, randomised design was followed. Two dosages w ere 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 t he 38 patients receiving the lower dose and 39 of the 40 patients rece iving the higher dose. In 3 patients from each group more lesions were seen following injection than before. The contrast medium improved th e delineation of abnormal structures and assessment of tumour size and increased their signal intensity indices in both groups, but especial ly at the higher dose. Administration of gadodiamide injection provide d more diagnostic information in about 75% of the patients, independen tly of the dose. There were no reports of discomfort, but 7 patients r eported adverse events considered unrelated to the gadodiamide injecti on. The two doses were found to be equally safe and efficient for diag nosis.