Clinical trial · Observational
A Comparative Study of MRI and Ultrasound for Detection of Primary Hepatocellular Carcinoma, Body Composition and Risk Factors for Decompensation in Liver Cirrhosis
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (6)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hepatocellular Carcinoma (HCC) | Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.85 |
| Liver Cirrhoses | — | UNRESOLVED | — |
| MRI | — | UNRESOLVED | — |
| Portal Hypertension Related to Cirrhosis | — | UNRESOLVED | — |
| Sarcopenia in Liver Cirrhosis | — | UNRESOLVED | — |
| Ultrasound | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (1)
- label
- Adult patients with liver cirrhosis without prior hepatocellular carcinoma
Primary outcomes (13)
- measure
- Lesion at high risk for hepatocellular carcinoma (HCC) - (LI RADS 4-5)
- timeFrame
- Baseline visit
- description
- A nodule on MRI classified as LI-RADS 4 or 5 according to the American College of Radiology (ACR) LI-RADS criteria.
- measure
- Lesion at high risk for hepatocellular carcinoma (HCC) - (LI RADS 4-5)
- timeFrame
- Visit 2 (6 months)
- description
- A nodule on MRI classified as LI-RADS 4 or 5 according to the American College of Radiology (ACR) LI-RADS criteria.
- measure
- Lesion at high risk for hepatocellular carcinoma (HCC) - (LI RADS 4-5)
- timeFrame
- Visit 3 (12 months)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available