NCT05502198Recruiting
Relevance of Sarcopenia in Advanced Liver Disease
A Rapid, Non-invasive, Clinical Surveillance for CachExia, Sarcopenia, Portal Hypertension and Hepatocellular Carcinoma in End-Stage Liver Disease
Source: ClinicalTrials.gov · Last updated 24 Aug 2023 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 150 (estimated)
- First submitted
- 15 Feb 2022
- Start date
- 1 Feb 2021
- Primary completion date
- 30 Jun 2025
- Lead sponsor
- Linkoeping University
- NCT number
- NCT05502198
What you commit to
- Study type: Observational
- Planned participants: 150
- From 1 Feb 2021 to the primary completion date, 30 Jun 2025
- 3 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous liver transplant
Other
- Contraindications for MRI
- Subjects suffering from primary sclerosing cholangitis (PSC)
- Subjects diagnosed with Hepatic carcinoma (HCC)
Who the study is looking for
- 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.
- Age ≥18 years
- Written informed consent from the participant
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Department of Gastroenterology), District Hospital in Eksjö Coordinator of this site? Confirm its status | Eksjö | Sweden | Recruiting |
| Department of gastroenterology, County Hospital in Jönköping Coordinator of this site? Confirm its status | Jönköping | Sweden | Recruiting |
| Department of gastroenterology and hepatology Coordinator of this site? Confirm its status | Linköping | Sweden | Recruiting |
Related publications
- Prevalence and Significance of Combined Low Muscle Volume and High Muscle Fat in Patients with Child-Pugh A-B Cirrhosis.JHEP Rep · 2026 · PMID 42727707
This page is information, not medical advice. Discuss any trial with your doctor.