Comparison of Biannual Ultrasonography and Annual Unenhanced Magnetic Resonance Imaging as a Surveillance Test for HCC in Patients With Liver Cirrhosis
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
- 否
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
研究组 & 干预措施
LC group
LC group under surveillance of biannual ultrasonography and annual noncontrast liver MRI. Six month after the last MRI, contrast enhanced liver CT is performed to investigate presence of HCC.
干预措施: Biannual ultrasonography (Procedure)
LC group
LC group under surveillance of biannual ultrasonography and annual noncontrast liver MRI. Six month after the last MRI, contrast enhanced liver CT is performed to investigate presence of HCC.
干预措施: Annual noncontrast liver MRI (Procedure)
LC group
LC group under surveillance of biannual ultrasonography and annual noncontrast liver MRI. Six month after the last MRI, contrast enhanced liver CT is performed to investigate presence of HCC.
干预措施: Contrast enhanced liver CT (Procedure)
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
Jeong Min Lee
Professor
Seoul National University Hospital