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
- 10
- 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
- •Patients with cirrhosis (all causes of cirrhosis, except obscure causes such as vascular or congenital fibrosis) AND reduced visualisation of their liver on ultrasound (vB and vC).
- •The criteria of cirrhosis can be obtained with any of the following methods:
- •Histologically by liver biopsy
- •Past signs of decompensated liver disease such as ascites, encephalopathy, varices or bacterial peritonitis
- •Clinically suspicion of cirrhosis PLUS one of the following:
- •Radiological evidence of morphologic changes of the liver and evidence of portal hypertension on US, CT or MRI examinations, including the identification of hepatic surface nodularity, splenomegaly, portal collaterals, varices and ascites
- •Fibroscan (transient elastography) median liver stiffness >12.5 kPa, the Fibroscan must be performed by an experienced technician and interpreted by the hepatologist
- •Platelet count <100 (x10^9/L) with no alternative cause
- •Absence of previous history or current suspicion of HCC - Absence of HCC is defined by liver US, multiphase CT or contrast-enhanced MRI within 6 months prior to surveillance
- •Patient is able to comply with scheduled visits, evaluation plans and other study procedures in the opinion of the investigator
- •Patient is willing to provide written informed consent
排除标准
- •Contraindications to MRI scan (defibrillator, pacemaker, metallic foreign body, severe claustrophobia etc.)
- •Contraindications to gadolinium
- •Age above 85 years old or younger than 20 years old
- •Pregnancy or breast feeding
- •Any other condition which, in the opinion of the Investigator, would make the patient unsuitable for enrolment for the trial or could interfere with the completion of the study
研究组 & 干预措施
HCC surveillance with US and aNC-MRI
干预措施: Abbreviated non-contrast MRI of the liver (Diagnostic Test)
HCC surveillance with US and aNC-MRI
干预措施: Ultrasound surveillance (Diagnostic Test)
HCC surveillance with US and aNC-MRI
干预措施: Multiphase contrast-enhanced liver MRI (Diagnostic Test)
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