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


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.


CONCLUSIONS
Ferumoxides is a safe and efficacious contrast agent for the detection of focal liver lesions on T2-weighted images.
Ros
P R
PR
Department of Radiology, University of Florida College of Medicine, Gainesville 32610, USA.
Freeny
P C
PC
Harms
S E
SE
Seltzer
S E
SE
Davis
P L
PL
Chan
T W
TW
Stillman
A E
AE
Muroff
L R
LR
Runge
V M
VM
Nissenbaum
M A
MA
D003287:Contrast Media / Q000009:adverse effects; D003911:Dextrans; D005260:Female; D052203:Ferrosoferric Oxide; D006801:Humans; D007091:Image Processing, Computer-Assisted; D007501:Iron / Q000009:adverse effects; D008099:Liver / Q000000981:diagnostic imaging / Q000473:pathology*; D008107:Liver Diseases / Q000175:diagnosis*; D008113:Liver Neoplasms / Q000175:diagnosis* / Q000556:secondary*; D058185:Magnetite Nanoparticles; D008297:Male; D008875:Middle Aged; D010087:Oxides / Q000009:adverse effects; D013997:Time Factors; D014057:Tomography, X-Ray Computed
D003287:Contrast Media; D003911:Dextrans; D058185:Magnetite Nanoparticles; D010087:Oxides; D007501:Iron; C065507:ferumoxides; D052203:Ferrosoferric Oxide