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临床试验/NCT02854241
NCT02854241Unknown不适用

Comparison of Biannual Ultrasonography and Annual Unenhanced Magnetic Resonance Imaging as a Surveillance Test for HCC in Patients With Liver Cirrhosis

Seoul National University Hospital1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2016年7月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
40
试验地点
1
主要终点
sensitivity for detecting HCC

研究概览

简要总结

The purpose of this study is to investigate clinical feasibility of annual non-contrast magnetic resonance imaging for surveillance of hepatocellular carcinoma in high-risk group, in comparison with biannual ultrasonography.

详细描述

The purpose of this study is to investigate clinical feasibility of annual non-contrast magnetic resonance imaging for surveillance of hepatocellular carcinoma in high-risk group, in comparison with biannual ultrasonography. In addition, the relationship between non-contrast MR parameters and clinical manifestation of liver function is investigated.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Screening
盲法
None

入排标准

年龄范围
40 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • equal to or older than 40 years
  • under surveillance using biannual ultrasonography (USG) and presence of liver USG within 6 months (+/- 1month)
  • risk index is equal to or higher than 2.33 (Risk Index = 1.65 (if the prothrombin activity is <=75%) + 1.41 (if the age is 50 years or older) + 0.92 (if the platelet count is <=100x10(3)/mm3) + 0.74 (if the presence of HCV or HBsAg is positive)).
  • signed informed consent

排除标准

  • under 40 years
  • history of HCC
  • patients with pregnancy or nursing
  • any contraindication of MRI
  • any contraindication of CT

结局指标

主要结局

sensitivity for detecting HCC

时间窗: 6 months after last patient's MRI

次要结局

  • specificity for detecting HCC(6 months after last patient's MRI)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jeong Min Lee

Professor

Seoul National University Hospital

研究点 (1)

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