Alternative Surveillance Program for Prospective Cohort of a Super-high Risk Group of Developing HCC
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 199
- 试验地点
- 1
- 主要终点
- Comparison of alternative surveillance program (alternating focused MRI + US in 6 month interval) and conventional surveillance (biannual US) for HCC detection
研究概览
简要总结
In a high-risk group, ultrasonography at 6-month intervals and short-protocol magnetic resonance imaging at 1-year intervals were performed. sensitivity, specificity, positive and negative predictive values for very early stage HCC are compared between conventional (biannual US) and alternative surveillance test are compared
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •chronic hepatitis B or C
- •Child-Pugh classification A
- •HCC risk score >= -2.04
- •have not diagnosed with HCC
- •on surveillance program using US and negative on previous US within 6-8 months of enrollment
- •sign informed consent
排除标准
- •younger than 40 years or older than 70 years old
- •history of HCC
- •severe GFR or on HD/PD due to renal failure
- •contra-indication of MRI
- •congestive hepatopathy
- •iron deposition
- •pregnancy or nursing mother
- •non-viral hepatitis or liver cirrhosis
研究组 & 干预措施
US & MRI
All participants undergo biannual US (as a part of standard-of-care) and annual non-contrast focused MRI.
干预措施: Non-contrast focused MRI (Diagnostic Test)
结局指标
主要结局
Comparison of alternative surveillance program (alternating focused MRI + US in 6 month interval) and conventional surveillance (biannual US) for HCC detection
时间窗: up to one year
per-patient sensitivity, specificity, positive predictive value, negative predictive value for very early stage HCC, early stage HCC, all stage of HCC/liver cancer.
次要结局
- scan time of focused MRI(up to one month)
- comparison between false referral rates of biannual US and annual focused MRI(up to one year)
- diagnostic yield for HCC(up to one year)
- Comparison of annual focused MRI and biannual US for HCC detection(up to one year)
研究者
Jeong Hee Yoon
Clinical Professor
Seoul National University Hospital