Actively Recruiting

Age: 18Years +
All Genders
NCT05502198

Relevance of Sarcopenia in Advanced Liver Disease

Led by Linkoeping University · Updated on 2023-08-24

150

Participants Needed

3

Research Sites

490 weeks

Total Duration

On this page

Sponsors

L

Linkoeping University

Lead Sponsor

A

Amra Medical AB

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Relevance of Sarcopenia in Advanced Liver Disease

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Established or probable liver cirrhosis as determined by clinical practice, FibroScan, symptoms, biopsy, or radiology
  • Age 18 years or older
  • Written informed consent provided by the participant
Not Eligible

You will not qualify if you...

  • Contraindications for MRI
  • Diagnosis of primary sclerosing cholangitis (PSC)
  • Diagnosis of hepatocellular carcinoma (HCC)
  • Previous liver transplant

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 3 locations

1

Department of Gastroenterology), District Hospital in Eksjö

Eksjö, Sweden, 57581

Actively Recruiting

2

Department of gastroenterology, County Hospital in Jönköping

Jönköping, Sweden, 55185

Actively Recruiting

3

Department of gastroenterology and hepatology

Linköping, Sweden

Actively Recruiting

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Research Team

M

Mattias Ekstedt, MD, PhD

CONTACT

M

Mikael Forsgren, PhD

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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