A Comparative Study of MRI and Ultrasound for Detection of Primary Hepatocellular Carcinoma, Body Composition and Risk Factors for Decompensation in Liver Cirrhosis

NCT07291141 | Recruiting

• 2 other identifiers: 2024-02472-01CIV-23-08-043855
• Study Type: observational
• Target: 600
• Locations: 1 country
• Sites: 1

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.

Conditions

Liver Cirrhoses; Hepatocellular Carcinoma (HCC); Sarcopenia in Liver Cirrhosis; Portal Hypertension Related to Cirrhosis; MRI; Ultrasound

Keywords

Abbreviated MRI; Hepatocellular carcinoma; Liver cirrhosis; Sarcopenia

Outcome Measures

Primary Outcomes (13)

• Lesion at high risk for hepatocellular carcinoma (HCC) - (LI RADS 4-5)

  A nodule on MRI classified as LI-RADS 4 or 5 according to the American College of Radiology (ACR) LI-RADS criteria.

  Baseline visit

• Lesion at high risk for hepatocellular carcinoma (HCC) - (LI RADS 4-5)

  A nodule on MRI classified as LI-RADS 4 or 5 according to the American College of Radiology (ACR) LI-RADS criteria.

  Visit 2 (6 months)

• Lesion at high risk for hepatocellular carcinoma (HCC) - (LI RADS 4-5)

  A nodule on MRI classified as LI-RADS 4 or 5 according to the American College of Radiology (ACR) LI-RADS criteria.

  Visit 3 (12 months)

• Lesion at high risk for hepatocellular carcinoma (HCC) - (LI RADS 4-5)

  A nodule on MRI classified as LI-RADS 4 or 5 according to the American College of Radiology (ACR) LI-RADS criteria.

  Visit 4 (18 months)

• Lesion at high risk for hepatocellular carcinoma (HCC) - (US LI RADS 3)

  A nodule on ultrasound classified as US LI-RADS 3 according to the American College of Radiology (ACR) LI-RADS criteria

  Baseline visit

• Lesion at high risk for hepatocellular carcinoma (HCC) - (US LI RADS 3)

  A nodule on ultrasound classified as US LI-RADS 3 according to the American College of Radiology (ACR) LI-RADS criteria

  Visit 2 (6 months)

• Lesion at high risk for hepatocellular carcinoma (HCC) - (US LI RADS 3)

  A nodule on ultrasound classified as US LI-RADS 3 according to the American College of Radiology (ACR) LI-RADS criteria

  Visit 3 (12 months)

• Lesion at high risk for hepatocellular carcinoma (HCC) - (US LI RADS 3)

  A nodule on ultrasound classified as US LI-RADS 3 according to the American College of Radiology (ACR) LI-RADS criteria

  Visit 4 (18 months)

• The Muscle Assessment Score (MAsS)

  The Muscle Assessment Score (MAsS) combines thigh muscle z-score and muscle fat infiltration to detect muscle composition phenotypes.

  Baseline visit

• The Muscle Assessment Score (MAsS)

  The Muscle Assessment Score (MAsS) combines thigh muscle z-score and muscle fat infiltration to detect muscle composition phenotypes.

  Visit 2 (12 months)

• The Muscle Assessment Score (MAsS)

  The Muscle Assessment Score (MAsS) combines thigh muscle z-score and muscle fat infiltration to detect muscle composition phenotypes.

  Visit 3 (12 months)

• The Muscle Assessment Score (MAsS)

  The Muscle Assessment Score (MAsS) combines thigh muscle z-score and muscle fat infiltration to detect muscle composition phenotypes.

  Visit 4 (18 months)

• Liver associated clinical events (LACE)

  Any of clinical ascites, variceal bleeding, hepatic encephalopathy west haven \>= grade 2, hepatorenal syndrome, or hepatopulmonary syndrome.

  From enrollment and six months after the last study visit (after a total of 24 months).

Secondary Outcomes (19)

• 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)

  Baseline

• Liver stiffness (VCTE)

  Visit 2 (6 months)

Study Arms (1)

Adult patients with liver cirrhosis without prior hepatocellular carcinoma

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients with liver cirrhosis without prior hepatocellular carcinoma or liver transplant.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mattias Ekstedt: lead
• Antaros Medical: collaborator
• Amra Medical AB: collaborator
• Region Östergötland: collaborator
• Region Jönköping County: collaborator
• Västra Götalandsregionen: collaborator
• Region Stockholm: collaborator
• Örebro County Council: collaborator
• Uppsala County Council, Sweden: collaborator
• Norrlands Universitetssjukhus, Umea, Sweden: collaborator

Study Sites (1)

Department of gastroenterology and hepatology, University hospital in Linköping

Linköping, Select A State Or Province, S-58931, Sweden

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Serum, plasma, whole blood, liver biopsy.

MeSH Terms

Conditions

Carcinoma, Hepatocellular; Liver Cirrhosis; Sarcopenia

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Signs and Symptoms

Study Officials

• Mattias Ekstedt, MD, PhD

  Linkoeping University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mattias Ekstedt, MD, PhD

CONTACT

0046709296267; mattias.ekstedt@liu.se

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Consultant/Senior associate professor

Study Record Dates

• First Submitted: December 5, 2025
• First Posted: December 18, 2025
• Study Start: December 18, 2025
• Primary Completion (Estimated): December 1, 2029
• Study Completion (Estimated): December 1, 2031
• Last Updated: December 19, 2025

Record last verified: 2025-12

Locations

SE (1)