A Comparative Study of MRI and Ultrasound for Detection of Primary Hepatocellular Carcinoma, Body Composition and Risk Factors for Decompensation in Liver Cirrhosis
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 600
- 试验地点
- 1
- 主要终点
- Lesion at high risk for hepatocellular carcinoma (HCC) - (US LI RADS 3)
研究概览
简要总结
DETECT-HCC-ESLD is a prospective multicenter study designed to examine early detection and risk stratification of hepatocellular carcinoma (HCC) in individuals with advanced liver disease. Adults with cirrhosis of different etiologies are enrolled and followed longitudinally with structured clinical assessments and imaging at predefined intervals.
A key objective is to evaluate ultrasound and abbreviated MRI (AMRI) as surveillance modalities for HCC. The study examines detection performance, feasibility, and factors influencing image quality and interpretability.
The protocol also includes the study of body composition, focusing on how variations in adiposity and muscle mass may relate to imaging characteristics, disease progression, and HCC risk.
Longitudinal clinical and imaging data are used to explore prediction models aimed at identifying patients with differing levels of HCC risk. The study records outcomes such as incident HCC, liver-related complications, and mortality to support analyses of disease trajectories.
The DETECT-HCC-ESLD study provides a structured framework for collecting clinical, imaging, and body composition data over time, enabling detailed evaluation of surveillance strategies and risk patterns in advanced liver disease.
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
- •Patients with liver cirrhosis, according to clinical practice. Based on criteria such as elastography, symptoms, biopsy, or radiology.
- •Age ≥18 years ≤ 84
- •Written informed consent from the participant
排除标准
- •Contraindications for MRI (ferrrous material, claustrophobia)
- •Pregnancy
- •Diagnosis of primary sclerosing cholangitis (PSC)
- •Vascular liver disease
- •Congenital liver fibrosis
- •Previous diagnosis of hepatic carcinoma (HCC)
- •Previous liver transplant
结局指标
主要结局
Lesion at high risk for hepatocellular carcinoma (HCC) - (US LI RADS 3)
时间窗: Visit 4 (18 months)
A nodule on ultrasound classified as US LI-RADS 3 according to the American College of Radiology (ACR) LI-RADS criteria
Lesion at high risk for hepatocellular carcinoma (HCC) - (LI RADS 4-5)
时间窗: Visit 4 (18 months)
A nodule on MRI classified as LI-RADS 4 or 5 according to the American College of Radiology (ACR) LI-RADS criteria.
The Muscle Assessment Score (MAsS)
时间窗: Visit 4 (18 months)
The Muscle Assessment Score (MAsS) combines thigh muscle z-score and muscle fat infiltration to detect muscle composition phenotypes.
Liver associated clinical events (LACE)
时间窗: From enrollment and six months after the last study visit (after a total of 24 months).
Any of clinical ascites, variceal bleeding, hepatic encephalopathy west haven \>= grade 2, hepatorenal syndrome, or hepatopulmonary syndrome.
次要结局
- Hepatocellular carcinoma (HCC)(From enrollment and six months after last visit (a total of 24 months).)
- Treatment for hepatocellular carcinoma(From enrollment and six months after last visit (a total of 24 months).)
- Death(From enrollment and six months after last visit (a total of 24 months).)
- Liver stiffness (VCTE)(Visit 4 (18 months))
- Liver stiffness (MRE)(Visit 4 (18 months))
- Liver volume(Visit 4 (18 months))
- Spleen volume(Visit 4 (18 months))
研究者
Mattias Ekstedt
Consultant/Senior associate professor
Linkoeping University