Triple-dose versus standard-dose gadopentetate dimeglumine: a randomized study in 199 patients.

To investigate the safety, patient tolerance, and efficacy with 0.3 mmol/kg gadopentetate dimeglumine in magnetic resonance (MR) imaging of the central nervous system (CNS), a phase 3 trial was conducted in 199 patients with suspected CNS lesions. Patients received either 0.1 or 0.3 mmol/kg gadopentate dimeglumine (injection time, 15 seconds and 45 seconds, respectively). T1- and T2-weighted spin-echo sequences were performed at either 0.5 T or 1.5 T. In 80 patients with enhancing brain lesions, contrast-to-noise ratios (C/Ns) were calculated, and lesion-to-brain contrast was evaluated visually. Six patients (6%) in each dose group reported adverse events. Eight adverse events occurred with 0.1 mmol/kg and seven with 0.3 mmol/kg. Vital signs and laboratory values did not change significantly. C/N (P < .05) and visual assessment ratings were higher with 0.3 mmol/kg than with 0.1 mmol/kg. According to these preliminary results, 0.3 mmol/kg gadopentetate dimeglumine is safe and well tolerated when administered at approximately 1 mL/sec.