HCC Surveillance: Comparison of Abbreviated Non-contrast MRI and Ultrasound Surveillance in Cirrhotic Patients With Suboptimal Ultrasound Visualisation
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 476
- 试验地点
- 17
- 主要终点
- HCC detection with US surveillance versus aNC-MRI surveillance
研究概览
简要总结
All international guidelines recommend 6-monthly ultrasound surveillance for patients at risk for liver cancer (hepatocellular carcinoma or HCC), such as patients with cirrhosis. The aim of surveillance is to detect HCC at an early stage when it is still potentially curable. Currently only 4 out of 10 HCCs are detected at the early stage.
Ultrasound surveillance for HCC has a wide ranging sensitivity, dependent on many factors such as operator experience, patient body habitus and liver parenchymal heterogeneity due to chronic liver disease and cirrhosis. In a select group of patients, surveillance ultrasound can be suboptimal or near non-diagnostic.
Currently no guideline offers an alternative surveillance tool for patients who have suboptimal surveillance ultrasounds.
详细描述
The investigators plan to conduct a prospective study to examine the diagnostic performance of abbreviated non-contrast MRI (aNC-MRI) versus ultrasound, in a select group of cirrhotic patients with poor ultrasound visualisation.
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
- 20 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
HCC detection with US surveillance versus aNC-MRI surveillance
时间窗: 3 or 5 years
The detection of hepatic malignancy on the two modalities will be compared * Sensitivity, specificity, PPV and NPV of HCC detection with US surveillance vs aNC-MRI surveillance * Correlation with diagnostic imaging (multiphase CT or MRI) and/or histopathology as a reference standard For the diagnosis of HCC we will accept * Imaging diagnosis based on the Liver Imaging Reporting and Data System (LI-RADS) * Any pathological proof on biopsy or excision The HCC will then be staged based on the Barcelona clinic liver cancer (BCLC) staging system For the diagnosis of non-HCC hepatic malignancy we will accept * Imaging diagnosis based on the Liver Imaging Reporting and Data System (LI-RADS) * Any pathological proof on biopsy or excision
次要结局
未报告次要终点
研究者
Dr Jessica Yang
Principal Investigator
Concord Repatriation General Hospital