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

NCT ID: NCT07291141

Last Updated: 2025-12-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

600 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-12-18

Study Completion Date

2031-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Liver Cirrhoses Hepatocellular Carcinoma (HCC) Sarcopenia in Liver Cirrhosis Portal Hypertension Related to Cirrhosis MRI Ultrasound

Keywords

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Abbreviated MRI Hepatocellular carcinoma Liver cirrhosis Sarcopenia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Adult patients with liver cirrhosis without prior hepatocellular carcinoma

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Antaros Medical

INDUSTRY

Sponsor Role collaborator

Amra Medical AB

INDUSTRY

Sponsor Role collaborator

Region Östergötland

OTHER

Sponsor Role collaborator

Region Jönköping County

OTHER_GOV

Sponsor Role collaborator

Västra Götalandsregionen

OTHER

Sponsor Role collaborator

Region Stockholm

OTHER_GOV

Sponsor Role collaborator

Örebro County Council

OTHER_GOV

Sponsor Role collaborator

Uppsala County Council, Sweden

OTHER_GOV

Sponsor Role collaborator

Norrlands Universitetssjukhus, Umea, Sweden

UNKNOWN

Sponsor Role collaborator

Mattias Ekstedt

OTHER_GOV

Sponsor Role lead

Responsible Party

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Mattias Ekstedt

Consultant/Senior associate professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Mattias Ekstedt, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Linkoeping University

Locations

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Department of gastroenterology and hepatology, University hospital in Linköping

Linköping, Select A State Or Province, Sweden

Site Status RECRUITING

Countries

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Sweden

Central Contacts

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Mattias Ekstedt, MD, PhD

Role: CONTACT

Phone: 0046709296267

Email: [email protected]

Facility Contacts

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Mattias Ekstedt, MD, PhD

Role: primary

Other Identifiers

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CIV-23-08-043855

Identifier Type: OTHER

Identifier Source: secondary_id

2024-02472-01

Identifier Type: -

Identifier Source: org_study_id