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NCT Number: NCT07291141

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-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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Key information

Conditions

Liver Cirrhoses Adenocarcinoma Atrophy Carcinoma Carcinoma, Hepatocellular Digestive System Diseases Digestive System Neoplasms Fibrosis Hepatocellular Carcinoma (HCC) Liver Cirrhosis Liver Diseases Liver Neoplasms MRI Muscular Atrophy Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Pathologic Processes Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Portal Hypertension Related to Cirrhosis Sarcopenia Sarcopenia in Liver Cirrhosis Signs and Symptoms Ultrasound

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of gastroenterology and hepatology, University hospital in Linköping

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

Location status: Recruiting

Location contact

Mattias Ekstedt, MD, PhD

CONTACT

[email protected]

+46709296267

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

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

    Time frame: Baseline visit

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

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

    Time frame: 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.

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

    Time frame: 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.

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

    Time frame: 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.

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

    Time frame: Baseline visit

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

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

    Time frame: 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

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

    Time frame: 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

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

    Time frame: 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

  9. The Muscle Assessment Score (MAsS)

    Time frame: Baseline visit

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

  10. The Muscle Assessment Score (MAsS)

    Time frame: Visit 2 (12 months)

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

  11. The Muscle Assessment Score (MAsS)

    Time frame: Visit 3 (12 months)

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

  12. The Muscle Assessment Score (MAsS)

    Time frame: Visit 4 (18 months)

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

  13. Liver associated clinical events (LACE)

    Time frame: 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

  1. Hepatocellular carcinoma (HCC)

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

    HCC verified by pathology.

  2. Treatment for hepatocellular carcinoma

    Time frame: 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.

  3. Death

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

    All cause mortality

  4. Liver stiffness (VCTE)

    Time frame: Baseline

    Liver stiffness measured with Fibroscan

  5. Liver stiffness (VCTE)

    Time frame: Visit 2 (6 months)

    Liver stiffness measured with Fibroscan

  6. Liver stiffness (VCTE)

    Time frame: Visit 3 (12 months)

    Liver stiffness measured with Fibroscan

  7. Liver stiffness (VCTE)

    Time frame: Visit 4 (18 months)

    Liver stiffness measured with Fibroscan

  8. Liver stiffness (MRE)

    Time frame: Baseline

    Liver stiffness measured with magnetic resonance elastography (MRE)

  9. Liver stiffness (MRE)

    Time frame: Visit 2 (6 months)

    Liver stiffness measured with magnetic resonance elastography (MRE)

  10. Liver stiffness (MRE)

    Time frame: Visit 3 (12 months)

    Liver stiffness measured with magnetic resonance elastography (MRE)

  11. Liver stiffness (MRE)

    Time frame: Visit 4 (18 months)

    Liver stiffness measured with magnetic resonance elastography (MRE)

  12. Liver volume

    Time frame: Baseline

    Liver volume measured with MRI

  13. Liver volume

    Time frame: Visit 2 (6 months)

    Liver volume measured with MRI

  14. Liver volume

    Time frame: Visit 3 (12 months)

    Liver volume measured with MRI

  15. Liver volume

    Time frame: Visit 4 (18 months)

    Liver volume measured with MRI

  16. Spleen volume

    Time frame: Baseline

    Spleen volume measured with MRI

  17. Spleen volume

    Time frame: Visit 2 (6 months)

    Spleen volume measured with MRI

  18. Spleen volume

    Time frame: Visit 3 (12 months)

    Spleen volume measured with MRI

  19. Spleen volume

    Time frame: Visit 4 (18 months)

    Spleen volume measured with MRI

Study contacts

Contact information is provided by the study sponsor or research team.

Mattias Ekstedt, MD, PhD

CONTACT

[email protected]

0046709296267

Sponsors and collaborators

Lead sponsor

Mattias Ekstedt

Other Gov

Collaborators

  • Amra Medical AB
  • Antaros Medical
  • Region Jönköping County
  • Region Stockholm
  • Region Östergötland
  • University Hospital, Umeå
  • Uppsala County Council, Sweden
  • Västra Götalandsregionen
  • Örebro County Council

Registry information

Acronym: DETECT-HCC

Important dates

Study start
2025
Primary completion
2029
Study completion
2031
First posted
Dec 18, 2025
Registry last updated
Dec 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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