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
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
- 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
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
研究点 (1)
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