NCT05502198 Relevance of Sarcopenia in Advanced Liver Disease
| NCT ID | NCT05502198 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Linkoeping University |
| Condition | Liver Cirrhosis |
| Study Type | OBSERVATIONAL |
| Enrollment | 150 participants |
| Start Date | 2021-02-01 |
| Primary Completion | 2025-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 150 participants in total. It began in 2021-02-01 with a primary completion date of 2025-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Patients with established liver cirrhosis, or end-stage liver disease (ESLD), are at high risk of developing liver cancer (hepatic carcinoma; HCC), portal hypertension, and sarcopenia, all which lead to significant morbidity and mortality. In this patient group the annual incidence of HCC is c. 2-8% and these patients are therefore included in ultrasound HCC screening programs every 6 months. In this study, the investigators are aiming to assess sarcopenia, clinically significant portal hypertension (CSPH), and HCC with a single short magnetic resonance (MR) examination. A neck-to-knee MRI-examination will be acquired to derive body composition profile (BCP) measurements including visceral and abdominal subcutaneous adipose tissue (VAT and ASAT), thigh fat free muscle volume (FFMV) and muscle fat infiltration (MFI), as well as liver fat (PDFF), spleen volume, and liver stiffness. Images will be further processed by AMRA Medical AB. AMRA's solution includes FFMV in the context of virtual control groups (VCG; using AMRA's vast database) and MFI. Furthermore, the spleen volume will be used to monitor the development of portal hypertension and explored together with other BCP variables in relation to hepatic decompensation events. HCC screening will be performed using so-called abbreviated MRI (AMRI), which consists of time series of contrast-enhanced T1-weighted images. The AMRI images will be read by an experienced radiologist. In the literature the sensitivity of AMRI to detect HCC is above 80%, with a specificity of c. 95%, compared to ultrasound sensitivity of 60%. In treating ESLD there is a desire of physicians to be able to predict future decompensation events in order to initiate treatment to prolong survival. Moreover, the ability to assess processes of sarcopenia in the patient would be highly valuable for clinical practice due its severe clinical impact. Finally, ultrasound-based HCC screening has poor diagnostic performance and a MR-based screening approach would significantly improve treatment outcome as more treatable and earlier HCC may be identified.
Eligibility Criteria
Inclusion Criteria: 1. Established or probable liver cirrhosis according to clinical practice at the Department of Gastroenterology and Hepatology at Linköping University Hospital. This is not by necessity biopsy verified, it can be different criteria such as FibroScan, symptoms, biopsy, and radiology. 2. Age ≥18 years 3. Written informed consent from the participant Exclusion Criteria: 1. Contraindications for MRI 2. Subjects suffering from primary sclerosing cholangitis (PSC) 3. Subjects diagnosed with Hepatic carcinoma (HCC) 4. Previous liver transplant
Contact & Investigator
Mattias Ekstedt, MD, PhD
PRINCIPAL INVESTIGATOR
Linkoeping University
Frequently Asked Questions
Who can join the NCT05502198 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Liver Cirrhosis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05502198 currently recruiting?
Yes, NCT05502198 is actively recruiting participants. Contact the research team at mattias.ekstedt@liu.se for enrollment information.
Where is the NCT05502198 trial being conducted?
This trial is being conducted at Eksjö, Sweden, Jönköping, Sweden, Linköping, Sweden.
Who is sponsoring the NCT05502198 clinical trial?
NCT05502198 is sponsored by Linkoeping University. The principal investigator is Mattias Ekstedt, MD, PhD at Linkoeping University. The trial plans to enroll 150 participants.