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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorMattias Ekstedt

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Contraindications for MRI (ferrrous material, claustrophobia)

Pregnancy

Diagnosis of primary sclerosing cholangitis (PSC)

Vascular liver disease

Trial population

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

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

600 Participants
are grouped into 1 trial group
Group A: Adult patients with liver cirrhosis without prior hepatocellular carcinoma

Trial outcomes

Primary outcomes

1

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.

Time frame
Baseline visit
2

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.

Time frame
Visit 2 (6 months)
3

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.

Time frame
Visit 3 (12 months)
4

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.

Time frame
Visit 4 (18 months)

Secondary outcomes

1

Hepatocellular carcinoma (HCC)

HCC verified by pathology.

Time frame
From enrollment and six months after last visit (a total of 24 months).
2

Treatment for hepatocellular carcinoma

Treatment given to patients that develope HCC: ablation, resection, TACE, systemic treatment, or best supportive care.

Time frame
From enrollment and six months after last visit (a total of 24 months).
3

Death

All cause mortality

Time frame
From enrollment and six months after last visit (a total of 24 months).
4

Liver stiffness (VCTE)

Liver stiffness measured with Fibroscan

Time frame
Baseline

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Mattias Ekstedt

Lead sponsor

Linkoeping University

Sponsor institution

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

University Hospital, Umeå

Collaborator