Multicenter double-blind placebo-controlled study of gadopentetate dimeglumine as an MR contrast agent: evaluation in patients with cerebral lesions

A multicenter double-blind randomized study was designed to evaluate and compare the safety and diagnostic efficacy of gadopentetate dimeglumine (Gd-DTPA) (0.1 mmol/kg) against a saline placebo for use as an IV contrast agent for MR. The randomization code provided for a 2:1 ratio of Gd-DTPA and saline patients. Six investigators studied 88 patients with signs and symptoms of a cerebral lesion. Safety studies showed no clinically significant abnormal trends. Minor changes in blood pressure, pulse, and serum iron levels were noted in a higher percentage of Gd-DTPA patients.