Standardized Contrast-enhanced Ultrasound (CEUS) -Algorithms for the Non-invasive Diagnosis of Hepatocellular Carcinoma (HCC) in High-risk-patients - a Prospective German Multicenter Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 517
- 试验地点
- 1
- 主要终点
- Diagnostic value of standardised CEUS-based algorithms for the non-invasive diagnosis of HCC in high-risk patients
研究概览
简要总结
Aim of this prospective national multicenter study is to improve standardization of contrast-enhanced ultrasound (CEUS) in the non-invasive diagnosis of hepatocellular carcinoma (HCC) in high-risk patients.
The study is funded by the German Society for Ultrasound in Medicine (DEGUM).
详细描述
To date, CEUS criteria for non-invasive diagnosis of HCC include arterial phase hyperenhancement, followed by contrast washout in the portal venous or late phase. We would like to investigate the following points:
- whether arterial hyperenhancement alone is sufficient for the definite diagnosis of HCC in cirrhosis with CEUS
- whether a further clearly-defined point of assessment in the late phase after 4-6 minutes is of additional diagnostic value in focal liver lesions showing no contrast washout after 3 minutes
- diagnostic value of CEUS-based standardised diagnostic algorithms (ESCULAP = Erlanger Synopsis of Contrast Enhanced Ultrasound for Liver lesion Assessment in Patients at risk; CEUS LI-RADS = Contrast Enhanced Ultrasound Liver Imaging Reporting and Data System) for non-invasive diagnosis of HCC in high-risk patients (diagnostic accuracy, interobserver-variability, feasability in clinical Routine).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •high risk for HCC
- •focal liver lesion on B-mode ultrasound
排除标准
- •pre-treated HCC lesion
- •systemic therapy for HCC (sorafenib, regorafenib and others)
结局指标
主要结局
Diagnostic value of standardised CEUS-based algorithms for the non-invasive diagnosis of HCC in high-risk patients
时间窗: 2 years
Diagnostic accuracy, interobserver-variabilty and feasability in clinical routine for CEUS-based algorithms Reference Standard: histology / MRI
次要结局
- Standardisation of CEUS examinations(2 years)
- Diagnostic accuracy of CEUS in intrahepatic cholangiocellular carcinoma (ICC)(2 years)
- Non-inferiority of CEUS versus MRI for non-invasive diagnosis of HCC(2 years)
- Diagnostic value / dispensability of contrast washout for definite diagnosis of HCC with CEUS(2 years)
- Comparison of two CEUS-based algorithms(2 years)
- Influence of histological grading on contrast enhancement behaviour(2 years)
研究者
Dr. med. Barbara Schellhaas and Prof. Dr. med. Deike Strobel
MD
University Hospital Erlangen