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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

Full criteria on ClinicalTrials.gov

Sites (3)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Department of Gastroenterology), District Hospital in Eksjö
Coordinator of this site? Confirm its status
EksjöSwedenRecruiting
Department of gastroenterology, County Hospital in Jönköping
Coordinator of this site? Confirm its status
JönköpingSwedenRecruiting
Department of gastroenterology and hepatology
Coordinator of this site? Confirm its status
LinköpingSwedenRecruiting

Related publications

This page is information, not medical advice. Discuss any trial with your doctor.