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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 |
Meng-Su Zeng, Hui-Yi Ye, Liang Guo, Wei-Jun Peng, Jian-Ping Lu, Gao-Jun Teng, Yi Huan, Ping Li, Jian-Rong Xu, Chang-Hong Liang and Josy Breuer |
Shanghai, China
Author Affiliations: Department of Radiology, Zhongshan Hospital, Fudan University, Shanghai 200032, China (Zeng MS); Department of Radiology, General Hospital of PLA, Beijing 100853, China (Ye HY); Department of Radiology, First Affiliated Hospital, Soochow University, Suzhou 215006, China (Guo L); Department of Radiology, Cancer Hospital, Fudan University, Shanghai 200032, China (Peng WJ); Department of Radiology, Changhai Hospital, Second Military Medical University, Shanghai 200433, China (Lu JP); Department of Radiology, Zhongda Hospital, Southeast University, Nanjing 210009, China (Teng GJ); Department of Radiology, Xijing Hospital, Fourth Military Medical University, Xi'an 710032, China (Huan Y); Bayer HealthCare Company Ltd., Beijing 100020, China (Li P); Department of Radiology, Renji Hospital, Shanghai Jiaotong University, Shanghai 200127, China (Xu JR); Department of Radiology, Guangdong General Hospital, Guangzhou 510080, China (Liang CH); Bayer HealthCare/Bayer Schering Pharma AG, Berlin, Germany (Breuer J)
Corresponding Author: Meng-Su Zeng, Professor, Department of Radiology, Zhongshan Hospital, Fudan University, No.180 Fenglin Road, Shanghai 200032, China (Tel: 86-21-64041990ext2130; Fax: 86-21-64439906; Email: zeng.mengsu@zs-hospital.sh.cn) |
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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.
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