Menu
Recruiting NCT07291141

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

— Observational Liver Cirrhoses Hepatocellular Carcinoma (HCC) Sarcopenia in Liver Cirrhosis Portal Hypertension Related to Cirrhosis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Liver Cirrhoses, Hepatocellular Carcinoma (HCC), Sarcopenia in Liver Cirrhosis, Portal Hypertension Related to Cirrhosis. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Sweden
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Primary outcome measures

  • Lesion at high risk for hepatocellular carcinoma (HCC) - (LI RADS 4-5) [Time frame: Baseline visit]
  • Lesion at high risk for hepatocellular carcinoma (HCC) - (LI RADS 4-5) [Time frame: Visit 2 (6 months)]
  • Lesion at high risk for hepatocellular carcinoma (HCC) - (LI RADS 4-5) [Time frame: Visit 3 (12 months)]
  • Lesion at high risk for hepatocellular carcinoma (HCC) - (LI RADS 4-5) [Time frame: Visit 4 (18 months)]
  • Lesion at high risk for hepatocellular carcinoma (HCC) - (US LI RADS 3) [Time frame: Baseline visit]
  • Lesion at high risk for hepatocellular carcinoma (HCC) - (US LI RADS 3) [Time frame: Visit 2 (6 months)]
  • Lesion at high risk for hepatocellular carcinoma (HCC) - (US LI RADS 3) [Time frame: Visit 3 (12 months)]
  • Lesion at high risk for hepatocellular carcinoma (HCC) - (US LI RADS 3) [Time frame: Visit 4 (18 months)]
  • The Muscle Assessment Score (MAsS) [Time frame: Baseline visit]
  • The Muscle Assessment Score (MAsS) [Time frame: Visit 2 (12 months)]
Secondary outcome measures (12)
  • Hepatocellular carcinoma (HCC) [Time frame: From enrollment and six months after last visit (a total of 24 months).]
  • Treatment for hepatocellular carcinoma [Time frame: From enrollment and six months after last visit (a total of 24 months).]
  • Death [Time frame: From enrollment and six months after last visit (a total of 24 months).]
  • Liver stiffness (VCTE) [Time frame: Baseline]
  • Liver stiffness (VCTE) [Time frame: Visit 2 (6 months)]
  • Liver stiffness (VCTE) [Time frame: Visit 3 (12 months)]
  • Liver stiffness (VCTE) [Time frame: Visit 4 (18 months)]
  • Liver stiffness (MRE) [Time frame: Baseline]
  • Liver stiffness (MRE) [Time frame: Visit 2 (6 months)]
  • Liver stiffness (MRE) [Time frame: Visit 3 (12 months)]
  • Liver stiffness (MRE) [Time frame: Visit 4 (18 months)]
  • Liver volume [Time frame: Baseline]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Sweden · 1 center
  • Department of gastroenterology and hepatology, University hospital in Linköping — Linköping

Identifiers

NCT: NCT07291141 · 2024-02472-01 · CIV-23-08-043855

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗