MR imaging of the liver with resovist: Safety, efficacy, and pharmacodynamic properties

PURPOSE: To evaluate the safety, efficacy, and pharmacodynamic properties of a new superparamagnetic parenteral iron oxide contrast agent for magnetic resonance (MR) imaging. MATERIALS AND METHODS: Thirty-six patients 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 iron 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, vital signs were monitored, and adverse events were recorded. Lesion detection was assessed by two independent, blinded readers. RESULTS: No drug-related adverse events occurred. Serum iron and ferritin levels were increased at all dose levels. Partial thromboplastin time increased and factor XI level decreased 4 hours after injection of 16 mu mol Fe/kg. Lesion detection and diagnostic confidence were increased in patients 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 mol Fe/kg.