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Liver CirrhosesDETECT-HCCNCT07291141

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

An observational study of Liver Cirrhoses and Hepatocellular Carcinoma (HCC), run by Mattias Ekstedt at 1 site in Sweden.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
How many people
600 participants
Where
1 siteSweden
Study dates
18 Dec 2025to Dec 2031
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Mattias Ekstedt, MD, PhD contact

0046709296267

mattias.ekstedt@liu.se

Sweden1 site, 1 recruiting

  • Department of gastroenterology and hepatology, University hospital in Linköping

    Linköping, Select A State Or Province, S-58931

    Mattias Ekstedt, MD, PhD, +46709296267, mattias.ekstedt@liu.se

    Recruiting

Other trials in Sweden

About this study

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.

Read more

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.

Keywords
Abbreviated MRI, Hepatocellular carcinoma, Liver cirrhosis, Sarcopenia
Medical subject headings
Carcinoma, Hepatocellular, Liver Cirrhosis, Sarcopenia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT07291141
Study groupRoleWhat they receive
Adult patients with liver cirrhosis without prior hepatocellular carcinomaNot described

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: Visit 4 (18 months)

  5. 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

    Measured: Baseline visit

  6. 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

    Measured: Visit 2 (6 months)

  7. 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

    Measured: Visit 3 (12 months)

  8. 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

    Measured: Visit 4 (18 months)

  9. The Muscle Assessment Score (MAsS)

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

    Measured: Baseline visit

  10. The Muscle Assessment Score (MAsS)

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

    Measured: Visit 2 (12 months)

  11. The Muscle Assessment Score (MAsS)

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

    Measured: Visit 3 (12 months)

  12. The Muscle Assessment Score (MAsS)

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

    Measured: Visit 4 (18 months)

  13. Liver associated clinical events (LACE)

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

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

Secondary outcomes (19)

  1. Hepatocellular carcinoma (HCC)

    HCC verified by pathology.

    Measured: 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.

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

  3. Death

    All cause mortality

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

  4. Liver stiffness (VCTE)

    Liver stiffness measured with Fibroscan

    Measured: Baseline

  5. Liver stiffness (VCTE)

    Liver stiffness measured with Fibroscan

    Measured: Visit 2 (6 months)

  6. Liver stiffness (VCTE)

    Liver stiffness measured with Fibroscan

    Measured: Visit 3 (12 months)

  7. Liver stiffness (VCTE)

    Liver stiffness measured with Fibroscan

    Measured: Visit 4 (18 months)

  8. Liver stiffness (MRE)

    Liver stiffness measured with magnetic resonance elastography (MRE)

    Measured: Baseline

  9. Liver stiffness (MRE)

    Liver stiffness measured with magnetic resonance elastography (MRE)

    Measured: Visit 2 (6 months)

  10. Liver stiffness (MRE)

    Liver stiffness measured with magnetic resonance elastography (MRE)

    Measured: Visit 3 (12 months)

  11. Liver stiffness (MRE)

    Liver stiffness measured with magnetic resonance elastography (MRE)

    Measured: Visit 4 (18 months)

  12. Liver volume

    Liver volume measured with MRI

    Measured: Baseline

  13. Liver volume

    Liver volume measured with MRI

    Measured: Visit 2 (6 months)

  14. Liver volume

    Liver volume measured with MRI

    Measured: Visit 3 (12 months)

  15. Liver volume

    Liver volume measured with MRI

    Measured: Visit 4 (18 months)

  16. Spleen volume

    Spleen volume measured with MRI

    Measured: Baseline

  17. Spleen volume

    Spleen volume measured with MRI

    Measured: Visit 2 (6 months)

  18. Spleen volume

    Spleen volume measured with MRI

    Measured: Visit 3 (12 months)

  19. Spleen volume

    Spleen volume measured with MRI

    Measured: Visit 4 (18 months)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Dec 2025
  2. Study start18 Dec 2025
  3. Primary completionDec 2029 (estimated)
  4. Study completionDec 2031 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
600 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07291141
Sponsor's protocol ID
2024-02472-01
Other IDs
CIV-23-08-043855
Acronym
DETECT-HCC
Status last verified
Dec 2025
First submitted
5 Dec 2025
Last updated
19 Dec 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

An observational study of Liver Cirrhoses and Hepatocellular Carcinoma (HCC), run by Mattias Ekstedt at 1 site in Sweden.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 19 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Mattias Ekstedt, MD, PhD (0046709296267, mattias.ekstedt@liu.se), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Lesion at high risk for hepatocellular carcinoma (HCC) - (LI RADS 4-5) (time frame: Baseline visit). The study lists 13 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07291141.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2025.

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