HEPATIC MR-IMAGING WITH FERUMOXIDES - A MULTICENTER CLINICAL-TRIAL OFTHE SAFETY AND EFFICACY IN THE DETECTION OF FOCAL HEPATIC-LESIONS

PURPOSE: To assess the safety and diagnostic efficacy of intravenous f erumoxides, a superparamagnetic iron oxide, for depiction of focal hep atic lesions on magnetic resonance (MR) images. MATERIALS AND METHODS: This open-label study included 208 patients with known or suspected f ocal hepatic lesions. MR images were obtained before and 45 minutes to 4 hours after intravenous infusion of ferumoxides (10 mu mol/kg). The effect of ferumoxides on signal intensity of the liver was assessed w ith quantitative analysis. Safety was evaluated with patient monitorin g 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 im ages. 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.