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Gd-EOB-DTPA-enhanced magnetic resonance imaging for focal liver lesions in Chinese patients:a multicenter,open-label,phase Ⅲ study

查看全文 作　　者：Meng-Su [1]Zeng;Hui-Yi [2]Ye;Liang [3]Guo;Wei-Jun [4]Peng;Jian-Ping [5]Lu;Gao-Jun [6]Teng;Josy [7,8]Breuer;Yi [9]Huan;Ping [10]Li;Jian-Rong [11]Xu;Chang-Hong [12]Liang 高影响力作者 机构地区：[1]Department of Radiology,Zhongshan Hospital,Fudan University,No.180 Fenglin Road;[2]Departmentof Radiology,General Hospital of PLA;[3]Department of Radiology,First Affiliated Hospital,SoochowUniversity;[4]Department of Radiology,Cancer Hospital,Fudan University;[5]Department of Radiology,Changhai Hospital,Second Military MedicalUniversity;[6]Department of Radiology,Zhongda Hospital,Southeast University;[7]Bayer HealthCare;[8]Bayer Schering Pharma AG;[9]Department of Radiology,Xijing Hospital,Fourth Military MedicalUniversity;[10]Bayer HealthCare CompanyLtd;[11]Department of Radiology,RenjiHospital,Shanghai Jiaotong University;[12]Department of Radiology,Guangdong General Hospital高影响力机构 出　　处：《Hepatobiliary & Pancreatic Diseases International》索引2013年第12卷第6期,共10页高影响力期刊 基　　金：supported by a grant from Bayer HealthCare/Bayer Schering Pharma AG 摘　　要：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 liverspecific MR imaging contrast agent gadoxetate disodium(GdEOB-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 1cm.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. 关 键 词：gadoxetate DISODIUM magnetic resonance imaging LIVER FOCAL LIVER lesions
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