Actively Recruiting
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
Eligibility Criteria
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
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
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
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
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here