Medline ® Abstract for Reference 4
Hepatic MR imaging with ferumoxides: a multicenter clinical trial of the safety and efficacy in the detection of focal hepatic lesions.
Ros PR, Freeny PC, Harms SE, Seltzer SE, Davis PL, Chan TW, Stillman AE, Muroff LR, Runge VM, Nissenbaum MA
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 mumol/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.
Department of Radiology, University of Florida College of Medicine, Gainesville 32610, USA.