Hepatocellular Carcinoma (HCC), Liver Cirrhoses, MRI, Portal Hypertension Related to Cirrhosis, Sarcopenia in Liver Cirrhosis, Ultrasound
Conditions
Keywords
Abbreviated MRI, Hepatocellular carcinoma, Liver cirrhosis, Sarcopenia
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.
Interventions
None listed
Sponsors
Antaros Medical
Amra Medical AB
Region Östergötland
Region Jönköping County
Västra Götalandsregionen
Region Stockholm
Örebro County Council
Uppsala County Council, Sweden
Norrlands Universitetssjukhus, Umea, Sweden
Mattias Ekstedt
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Lesion at high risk for hepatocellular carcinoma (HCC) - (LI RADS 4-5) | Baseline visit | A nodule on MRI classified as LI-RADS 4 or 5 according to the American College of Radiology (ACR) LI-RADS criteria. |
| Lesion at high risk for hepatocellular carcinoma (HCC) - (US LI RADS 3) | Baseline visit | A nodule on ultrasound classified as US LI-RADS 3 according to the American College of Radiology (ACR) LI-RADS criteria |
| The Muscle Assessment Score (MAsS) | Baseline visit | The Muscle Assessment Score (MAsS) combines thigh muscle z-score and muscle fat infiltration to detect muscle composition phenotypes. |
| Liver associated clinical events (LACE) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Liver stiffness (MRE) | Baseline | Liver stiffness measured with magnetic resonance elastography (MRE) |
| Liver stiffness (VCTE) | Baseline | Liver stiffness measured with Fibroscan |
| Spleen volume | Baseline | Spleen volume measured with MRI |
| Liver volume | Baseline | Liver volume measured with MRI |
| Hepatocellular carcinoma (HCC) | From enrollment and six months after last visit (a total of 24 months). | HCC verified by pathology. |
| Treatment for hepatocellular carcinoma | From enrollment and six months after last visit (a total of 24 months). | Treatment given to patients that develope HCC: ablation, resection, TACE, systemic treatment, or best supportive care. |
| Death | From enrollment and six months after last visit (a total of 24 months). | All cause mortality |
Countries
Sweden
Contacts
Primary ContactMattias Ekstedt, MD, PhD
Outcome results
None listed