Actively Recruiting
A Comparative Study of MRI and Ultrasound for Detection of Primary Hepatocellular Carcinoma, Body Composition and Risk Factors for Decompensation in Liver Cirrhosis
Led by Mattias Ekstedt · Updated on 2025-12-19
600
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
Sponsors
M
Mattias Ekstedt
Lead Sponsor
A
Antaros Medical
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are investigating early detection and risk assessment of hepatocellular carcinoma (HCC) in adults with advanced liver disease, specifically those with liver cirrhosis from various causes. This prospective multicenter study aims to compare ultrasound and abbreviated MRI (AMRI) as surveillance tools to assess their ability to detect HCC, as well as to study how body composition, such as fat and muscle levels, relates to disease progression and HCC risk. Participants with cirrhosis undergo regular clinical evaluations and imaging tests at set intervals, including ultrasound and abbreviated MRI scans. The study collects detailed data on body composition and tracks clinical outcomes like liver-related complications and mortality. These assessments occur over multiple visits, including baseline and follow-ups at 6, 12, and 18 months, with additional monitoring for up to 24 months to observe new cases of HCC and disease progression. During the study, participants receive structured exams, imaging, and body composition measurements at each visit. Researchers evaluate lesion risk for HCC using LI-RADS criteria and measure muscle mass through the Muscle Assessment Score. They also monitor liver stiffness and organ volumes at baseline and follow-up visits. The study's goal is to develop prediction models based on these clinical and imaging data to better understand HCC risk and liver disease progression over time.
CONDITIONS
Brief Title
A Comparative Study of MRI and Ultrasound for Detection of Primary Hepatocellular Carcinoma, Body Composition and Risk Factors for Decompensation in Liver Cirrhosis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with liver cirrhosis diagnosed by clinical practice including elastography, symptoms, biopsy, or radiology
- Age between 18 and 84 years
- Provided written informed consent to participate
You will not qualify if you...
- Contraindications for MRI such as presence of ferrous material or claustrophobia
- Pregnancy
- Diagnosis of primary sclerosing cholangitis (PSC)
- Vascular liver disease
- Congenital liver fibrosis
- Previous diagnosis of hepatocellular carcinoma (HCC)
- Previous liver transplant
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 18 months
Participants undergo MRI and ultrasound imaging to detect lesions and assess liver and spleen volumes and stiffness, as well as muscle assessment.
4 visits at baseline, 6 months, 12 months, and 18 months (in-person)
Duration - 6 months after the last study visit (total monitoring duration 24 months)
Participants are monitored for liver-associated clinical events, hepatocellular carcinoma, treatments, and death.
Monitoring occurs after the last imaging visit without scheduled visits
Trial Site Locations
Total: 1 location
1
Department of gastroenterology and hepatology, University hospital in Linköping
Linköping, Select A State Or Province, Sweden, S-58931
Actively Recruiting
Research Team
M
Mattias Ekstedt, MD, PhD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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