Safety profile of ultrasmall superparamagnetic iron oxide ferumoxtran-10: phase II clinical trial data.

摘要: The safety data from the phase II clinical trial of ferumoxtran-10, an ultrasmall superparamagnetic iron oxide contrast agent, are presented. One hundred and four patients with focal liver or spleen pathologies underwent ferumoxtran-10-enhanced magnetic resonance (MR) imaging at doses 0.8, 1.1, 1.7 mg Fe/kg. Overall, 15% reported a total 33 adverse events, regardless causality. events most frequently seen were dyspnea (3.8%), chest pain (2.9%), rash (2.9%). No serious during 48 hour observation period. There no clinically significant effects on vital signs, physical examination, laboratory results. Ferumoxtran-10 is safe well tolerated MR agent.