title: Gd-EOB-DTPA-enhanced magnetic resonance imaging for focal liver lesions in Chinese patients: a multicenter, open-label, phase III study.
abstract: BACKGROUND
  Contrast agents help to improve visibility in magnetic resonance (MR) imaging. However, owing to the large interstitial spaces of the liver, there is a reduction in the natural contrast gradient between lesions and healthy tissue. This study was undertaken to evaluate the efficacy and safety of the liver-specific MR imaging contrast agent gadoxetate disodium (Gd-EOB-DTPA) in Chinese patients.
  
  
  METHODS
  This was a single-arm, open-label, multicenter study in patients with known or suspected focal liver lesions referred for contrast-enhanced MR imaging. MR imaging was performed in 234 patients before and after a single intravenous bolus of Gd-EOB-DTPA (0.025 mmol/kg body weight). Images were evaluated by clinical study investigators and three independent, blinded radiologists. The primary efficacy endpoint was sensitivity in lesion detection.
  
  
  RESULTS
  Gd-EOB-DTPA improved sensitivity in lesion detection by 9.46% compared with pre-contrast imaging for the average of the three blinded readers (94.78% vs 85.32% for Gd-EOB-DTPA vs pre-contrast, respectively). Improvements in detection were more pronounced in lesions less than 1 cm. Gd-EOB-DTPA improved diagnostic accuracy in lesion classification.
  
  
  CONCLUSIONS
  This open-label study demonstrated that Gd-EOB-DTPA improves diagnostic sensitivity in liver lesions, particularly in those smaller than 1 cm. Gd-EOB-DTPA also significantly improves the diagnostic accuracy in lesion classification, and furthermore, Gd-EOB-DTPA is safe in Chinese patients with liver lesions.
authors: Department of Radiology, Zhongshan Hospital, Fudan University, Shanghai 200032, China. zeng.mengsu@zs-hospital.sh.cn.
authors: Meng-Su
authors: MS
authors: Zeng
authors: Hui-Yi
authors: HY
authors: Ye
authors: Liang
authors: L
authors: Guo
authors: Wei-Jun
authors: WJ
authors: Peng
authors: Jian-Ping
authors: JP
authors: Lu
authors: Gao-Jun
authors: GJ
authors: Teng
authors: Yi
authors: Y
authors: Huan
authors: Ping
authors: P
authors: Li
authors: Jian-Rong
authors: JR
authors: Xu
authors: Chang-Hong
authors: CH
authors: Liang
authors: Josy
authors: J
authors: Breuer
mesh_terms: D000328:Adult; D000368:Aged; D044466:Asian People; D002681:China; D003287:Contrast Media / Q000008:administration & dosage; D005260:Female; D019786:Gadolinium DTPA / Q000008:administration & dosage; D006801:Humans; D007275:Injections, Intravenous; D008113:Liver Neoplasms / Q000175:diagnosis* / Q000453:epidemiology / Q000473:pathology*; D008279:Magnetic Resonance Imaging / Q000379:methods*; D008297:Male; D008875:Middle Aged; D061214:Patient Safety; D012680:Sensitivity and Specificity; D016896:Treatment Outcome
chemical_list: D003287:Contrast Media; C073590:gadolinium ethoxybenzyl DTPA; D019786:Gadolinium DTPA