title: Improved characterization of focal liver lesions with liver-specific gadoxetic acid disodium-enhanced magnetic resonance imaging: a multicenter phase 3 clinical trial.
abstract: 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.
authors.affiliation: Department of Radiological Sciences, UCLA, Los Angeles, CA 90095-1721, USA. sraman@mednet.ucla.edu
authors.forename: Steven S
authors.initials: SS
authors.lastname: Raman
authors.forename: Christopher
authors.initials: C
authors.lastname: Leary
authors.forename: David A
authors.initials: DA
authors.lastname: Bluemke
authors.forename: Marco
authors.initials: M
authors.lastname: Amendola
authors.forename: Dushyant
authors.initials: D
authors.lastname: Sahani
authors.forename: Jeffrey D
authors.initials: JD
authors.lastname: McTavish
authors.forename: Jeffrey
authors.initials: J
authors.lastname: Brody
authors.forename: Eric
authors.initials: E
authors.lastname: Outwater
authors.forename: Donald
authors.initials: D
authors.lastname: Mitchell
authors.forename: Douglas H
authors.initials: DH
authors.lastname: Sheafor
authors.forename: Jeff
authors.initials: J
authors.lastname: Fidler
authors.forename: Isaac R
authors.initials: IR
authors.lastname: Francis
authors.forename: Richard C
authors.initials: RC
authors.lastname: Semelka
authors.forename: Kohkan
authors.initials: K
authors.lastname: Shamsi
authors.forename: Simone
authors.initials: S
authors.lastname: Gschwend
authors.forename: David R
authors.initials: DR
authors.lastname: Feldman
authors.forename: Josy
authors.initials: J
authors.lastname: Breuer
mesh_terms: 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
chemical_list: D003287:Contrast Media; C073590:gadolinium ethoxybenzyl DTPA; D019786:Gadolinium DTPA