Improved characterization of focal liver lesions with liver-specific gadoxetic acid disodium-enhanced magnetic resonance imaging: a multicenter phase 3 clinical trial.
OBJECTIVE
To evaluate the safety of gadoxetic acid disodium (Gd-EOB-DTPA) magnetic resonance imaging (MRI) and its efficacy in characterizing liver lesions.


METHODS
Lesion characterization and classification using combined (unenhanced and Gd-EOB-DTPA-enhanced) MRI were compared with those using unenhanced MRI and contrast-enhanced spiral computed tomography (CT) using on-site clinical and off-site blinded evaluations for patients with focal liver lesions.


RESULTS
Gadoxetic acid disodium was well tolerated in this study. For the clinical evaluation, more lesions were correctly characterized using combined (unenhanced and Gd-EOB-DTPA-enhanced) MRI than using unenhanced MRI and spiral CT (96% vs 84% and 85%, respectively; P < or = 0.0008). For the blinded evaluation, more lesions were correctly characterized using combined MRI compared with using unenhanced MRI (61%-76% vs 48%-65%, respectively; P < or = 0.0012 for 2/3 readers); when compared with spiral CT, a similar proportion of lesions were correctly characterized.


CONCLUSIONS
Gadoxetic acid disodium-enhanced MRI is of clinical benefit relative to unenhanced MRI and spiral CT for a radiological diagnosis of liver lesions.
Raman
Steven S
SS
Department of Radiological Sciences, UCLA, Los Angeles, CA 90095-1721, USA. sraman@mednet.ucla.edu
Leary
Christopher
C
Bluemke
David A
DA
Amendola
Marco
M
Sahani
Dushyant
D
McTavish
Jeffrey D
JD
Brody
Jeffrey
J
Outwater
Eric
E
Mitchell
Donald
D
Sheafor
Douglas H
DH
Fidler
Jeff
J
Francis
Isaac R
IR
Semelka
Richard C
RC
Shamsi
Kohkan
K
Gschwend
Simone
S
Feldman
David R
DR
Breuer
Josy
J
D000328:Adult; D003287:Contrast Media; D005260:Female; D019786:Gadolinium DTPA; D006801:Humans; D008107:Liver Diseases / Q000175:diagnosis* / Q000000981:diagnostic imaging; D008279:Magnetic Resonance Imaging / Q000379:methods*; D008297:Male; D012680:Sensitivity and Specificity; D036542:Tomography, Spiral Computed; D014481:United States
D003287:Contrast Media; C073590:gadolinium ethoxybenzyl DTPA; D019786:Gadolinium DTPA