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, 600 participants, Mattias Ekstedt

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Registry	NCT07291141, acronym DETECT-HCC
Status	Recruiting
Study type	Observational
Enrollment	600 (Estimated)
Sponsor	Mattias Ekstedt (Other gov); collaborators: Antaros Medical, Amra Medical AB, Region Östergötland, Region Jönköping County, Västra Götalandsregionen, Region Stockholm, Örebro County Council, Uppsala County Council, Sweden, University Hospital, Umeå
Conditions	Liver Cirrhoses, Hepatocellular Carcinoma (HCC), Sarcopenia in Liver Cirrhosis, Portal Hypertension Related to Cirrhosis, MRI, Ultrasound
Dates	start 2025-12-18, primary completion 2029-12-01 (estimated), completion 2031-12-01 (estimated), first posted 2025-12-18, last updated 2025-12-19
Locations	1 site in Sweden

-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.

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+Arms and interventions

Arm	Type	Interventions	Description
Adult patients with liver cirrhosis without prior hepatocellular carcinoma

+Outcome measures

Primary outcomes

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) - (LI RADS 4-5) [Visit 2 (6 months)]: 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) - (LI RADS 4-5) [Visit 3 (12 months)]: 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) - (LI RADS 4-5) [Visit 4 (18 months)]: 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
Lesion at high risk for hepatocellular carcinoma (HCC) - (US LI RADS 3) [Visit 2 (6 months)]: A nodule on ultrasound classified as US LI-RADS 3 according to the American College of Radiology (ACR) LI-RADS criteria
Lesion at high risk for hepatocellular carcinoma (HCC) - (US LI RADS 3) [Visit 3 (12 months)]: A nodule on ultrasound classified as US LI-RADS 3 according to the American College of Radiology (ACR) LI-RADS criteria
Lesion at high risk for hepatocellular carcinoma (HCC) - (US LI RADS 3) [Visit 4 (18 months)]: 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.
The Muscle Assessment Score (MAsS) [Visit 2 (12 months)]: The Muscle Assessment Score (MAsS) combines thigh muscle z-score and muscle fat infiltration to detect muscle composition phenotypes.
The Muscle Assessment Score (MAsS) [Visit 3 (12 months)]: The Muscle Assessment Score (MAsS) combines thigh muscle z-score and muscle fat infiltration to detect muscle composition phenotypes.
The Muscle Assessment Score (MAsS) [Visit 4 (18 months)]: 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 outcomes

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
Liver stiffness (VCTE) [Baseline]: Liver stiffness measured with Fibroscan
Liver stiffness (VCTE) [Visit 2 (6 months)]: Liver stiffness measured with Fibroscan
Liver stiffness (VCTE) [Visit 3 (12 months)]: Liver stiffness measured with Fibroscan
Liver stiffness (VCTE) [Visit 4 (18 months)]: Liver stiffness measured with Fibroscan
Liver stiffness (MRE) [Baseline]: Liver stiffness measured with magnetic resonance elastography (MRE)
Liver stiffness (MRE) [Visit 2 (6 months)]: Liver stiffness measured with magnetic resonance elastography (MRE)
Liver stiffness (MRE) [Visit 3 (12 months)]: Liver stiffness measured with magnetic resonance elastography (MRE)
Liver stiffness (MRE) [Visit 4 (18 months)]: Liver stiffness measured with magnetic resonance elastography (MRE)
Liver volume [Baseline]: Liver volume measured with MRI
Liver volume [Visit 2 (6 months)]: Liver volume measured with MRI
Liver volume [Visit 3 (12 months)]: Liver volume measured with MRI
Liver volume [Visit 4 (18 months)]: Liver volume measured with MRI
Spleen volume [Baseline]: Spleen volume measured with MRI
Spleen volume [Visit 2 (6 months)]: Spleen volume measured with MRI
Spleen volume [Visit 3 (12 months)]: Spleen volume measured with MRI
Spleen volume [Visit 4 (18 months)]: Spleen volume measured with MRI

+Eligibility

Sex: All, ages: 18 Years to any

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

+Locations (1)

Facility	City	Country	Status
Department of gastroenterology and hepatology, University hospital in Linköping	Linköping, Select A State Or Province	Sweden	Recruiting

+Investigators

Mattias Ekstedt, MD, PhD, Principal investigator, Linkoeping University