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

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.

Study Overview

• Status: Recruiting
• Conditions: MRI; Hepatocellular Carcinoma (HCC); Ultrasound; Liver Cirrhoses; Portal Hypertension Related to Cirrhosis; Sarcopenia in Liver Cirrhosis

• Study Type: Observational
• Enrollment (Estimated): 600

Contacts and Locations

• Study Contact: Name: Mattias Ekstedt, MD, PhD; Phone Number: 0046709296267; Email: mattias.ekstedt@liu.se

Study Locations

• Sweden
  • Select A State Or Province
    • Linköping, Select A State Or Province, Sweden, S-58931
      • Recruiting
      • Department of gastroenterology and hepatology, University hospital in Linköping
      • Contact: Mattias Ekstedt, MD, PhD; Phone Number: +46709296267; Email: mattias.ekstedt@liu.se

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Adult patients with liver cirrhosis without prior hepatocellular carcinoma

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hepatocellular carcinoma (HCC)	HCC verified by pathology.	From enrollment and six months after last visit (a total of 24 months).
Treatment for hepatocellular carcinoma	Treatment given to patients that develope HCC: ablation, resection, TACE, systemic treatment, or best supportive care.	From enrollment and six months after last visit (a total of 24 months).
Death	All cause mortality	From enrollment and six months after last visit (a total of 24 months).
Liver stiffness (VCTE)	Liver stiffness measured with Fibroscan	Baseline
Liver stiffness (VCTE)	Liver stiffness measured with Fibroscan	Visit 2 (6 months)
Liver stiffness (VCTE)	Liver stiffness measured with Fibroscan	Visit 3 (12 months)
Liver stiffness (VCTE)	Liver stiffness measured with Fibroscan	Visit 4 (18 months)
Liver stiffness (MRE)	Liver stiffness measured with magnetic resonance elastography (MRE)	Baseline
Liver stiffness (MRE)	Liver stiffness measured with magnetic resonance elastography (MRE)	Visit 2 (6 months)
Liver stiffness (MRE)	Liver stiffness measured with magnetic resonance elastography (MRE)	Visit 3 (12 months)
Liver stiffness (MRE)	Liver stiffness measured with magnetic resonance elastography (MRE)	Visit 4 (18 months)
Liver volume	Liver volume measured with MRI	Baseline
Liver volume	Liver volume measured with MRI	Visit 2 (6 months)
Liver volume	Liver volume measured with MRI	Visit 3 (12 months)
Liver volume	Liver volume measured with MRI	Visit 4 (18 months)
Spleen volume	Spleen volume measured with MRI	Baseline
Spleen volume	Spleen volume measured with MRI	Visit 2 (6 months)
Spleen volume	Spleen volume measured with MRI	Visit 3 (12 months)
Spleen volume	Spleen volume measured with MRI	Visit 4 (18 months)

Collaborators and Investigators

• Sponsor: Mattias Ekstedt
• Collaborators: Örebro County Council; Region Östergötland; Region Jönköping County; Region Stockholm; Uppsala County Council, Sweden; Antaros Medical; Amra Medical AB; Västra Götalandsregionen; Norrlands Universitetssjukhus, Umea, Sweden
• Investigators: Principal Investigator: Mattias Ekstedt, MD, PhD, Linkoeping University

Study record dates

Study Major Dates

• Study Start (Actual): December 18, 2025
• Primary Completion (Estimated): December 1, 2029
• Study Completion (Estimated): December 1, 2031

Study Registration Dates

• First Submitted: December 5, 2025
• First Submitted That Met QC Criteria: December 5, 2025
• First Posted (Estimated): December 18, 2025

Study Record Updates

• Last Update Posted (Actual): December 19, 2025
• Last Update Submitted That Met QC Criteria: December 18, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Sarcopenia; Hepatocellular carcinoma; Liver cirrhosis; Abbreviated MRI
• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Neuromuscular Manifestations; Pathologic Processes; Neoplasms by Site; Neoplasms; Pathological Conditions, Anatomical; Neoplasms by Histologic Type; Digestive System Neoplasms; Digestive System Diseases; Liver Diseases; Neoplasms, Glandular and Epithelial; Adenocarcinoma; Liver Neoplasms; Carcinoma; Muscular Atrophy; Atrophy; Fibrosis; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Carcinoma, Hepatocellular; Liver Cirrhosis; Sarcopenia
• Other Study ID Numbers: 2024-02472-01; CIV-23-08-043855 (Other Identifier: Swedish Medical Products Agency)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No