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.

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