A multicenter, randomized, double-blind study to evaluate the safety, tolerability, and efficacy of OptiMARK (gadoversetamide injection) compared with magnevist (gadopentetate dimeglumine) in patients with liver pathology: Results of a phase III clinical trial

The purpose of this study was to evaluate the safety and efficacy of OptiMA RK (gadoversetamide injection) compared with Magnevist (gadopentetate dimeg lumine) in hepatic MRI of patients with suspected liver pathology. A Phase III, multicenter, randomized, double-blind, parallel group study was perfor med in adults with suspected liver pathology. Ail patients underwent contra st-enhanced computed tomography within 3 weeks prior to magnetic resonance scanning. Ninety-nine patients received OptiMARK, and 94 patients received Magnevist at a dose of 0.1 mmol/kg, Precontrast T1- and T2-weighted spin-ec ho imaging and T1-weighted gradient-echo imaging were performed, followed b y T1-weighted gradient-echo imaging at 15-20 seconds, 1 minute, and 5 minut es after intravenous contrast injection. Three primary efficacy endpoints ( confidence in lesion diagnosis, level of conspicuity, and lesion border del ineation) were evaluated on the precontrast image set and compared with the pre plus postcontrast image set. Vital signs, physical examination, electr ocardiograms (ECGs), and laboratory parameters (chemistry, hematology, and urinalysis) were measured at various time points. Adverse events were recor ded. The study design and statistical analyses were chosen to demonstrate p resumed equivalence of OptiMARK and Magnevist, There were no statistically significant differences in efficacy between OptiMARK and Magnevist as asses sed by either blinded readers or the on-site principal investigators. No se rious or unexpected adverse events were noted. Of the 193 patients receivin g contrast media, 82 experienced a total of 154 adverse events, Thirty-thre e (21.4%) of these 154 adverse events were felt by the on-site investigator s to be probably related to either study agent: 15 events in 9 patients in the OptiMARK group, and 18 events in 13 patients in the Magnevist group. He adache was the most common adverse event, occurring in 10.1% of the OptiMAR K patients and 12.8% of the Magnevist patients. No clinically relevant tren ds were observed in any laboratory parameter or ECG findings in either trea tment group. The results demonstrate the safety, efficacy, and equivalence of OptiMARK and Magnevist at a dose of 0.1 mmol/kg in hepatic magnetic reso nance imaging of patients with suspected liver pathology. J, Magn. Reson. I maging 1999:9: 240-250. (C) 1999 Wiley-Liss, Inc.