MR-IMAGING OF THE LIVER WITH RESOVIST - SAFETY, EFFICACY, AND PHARMACODYNAMIC PROPERTIES

PURPOSE: To evaluate the safety, efficacy, and pharmacodynamic propert ies of a new superparamagnetic parenteral iron oxide contrast agent fo r magnetic resonance (MR) imaging. MATERIALS AND METHODS: Thirty-six p atients with liver lesions received a bolus injection of Resovist (SH U 555 A; Schering, Berlin, Germany) at a dose of 4, 8, or 16 mu mol ir on per kilogram body weight (mu mol Fe/kg). Fast low-angle shot, spin- echo, and turbo gradient spin-echo MR images were obtained before and 10, 40, and 70 minutes after injection. Blood samples were obtained, v ital signs were monitored, and adverse events were recorded. Lesion de tection was assessed by two independent, blinded readers. RESULTS: No drug-related adverse events occurred. Serum iron and ferritin levels w ere increased at all dose levels. Partial thromboplastin time increase d and factor XI level decreased 4 hours after injection of 16 mu mol F e/kg. Lesion detection and diagnostic confidence were increased in pat ients who received 4 or 8 mu mol Fe/kg, with no further increase with a 16-mu mol dose. CONCLUSION: Resovist is safe and effective. The best MR imaging results were obtained 40 minutes after injection of 8 mu m ol Fe/kg.