Hepatic MR imaging with ferumoxides: A multicenter clinical trial of the safety and efficacy in the detection of focal hepatic lesions

PURPOSE: To assess the safety and diagnostic efficacy of intravenous ferumoxides, a superparamagnetic iron oxide, for depiction of focal hepatic lesions on magnetic resonance (MR) images. MATERIALS AND METHODS: This open- label study included 208 patients with known or suspected focal hepatic lesions. MR images were obtained before and 45 minutes to 4 hours after intravenous infusion of ferumoxides (10 μmol/kg). The effect of ferumoxides on signal intensity of the liver was assessed with quantitative analysis. Safety was evaluated with patient monitoring and laboratory measurements. RESULTS: Mean lesion-to-liver contrast-to-noise ratio on T2-weighted images was 9.1 on unenhanced images and 12.7 on enhanced images. Signal intensity of normal liver on enhanced images decreased to 37% of that on unenhanced images. In blinded image evaluations, additional lesions were identified on 27% of enhanced images. No serious adverse events occurred. CONCLUSION: Ferumoxides is a safe and efficacious contrast agent for the detection of focal liver lesions on T2-weighted images.