NCT07291141 A Comparative Study of MRI and Ultrasound for Detection of Primary Hepatocellular Carcinoma, Body Composition and Risk Factors for Decompensation in Liver Cirrhosis
| NCT ID | NCT07291141 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Mattias Ekstedt |
| Condition | Liver Cirrhoses |
| Study Type | OBSERVATIONAL |
| Enrollment | 600 participants |
| Start Date | 2025-12-18 |
| Primary Completion | 2029-12 |
Trial Parameters
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Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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