About this trial
Nonalcoholic fatty liver disease is the most common liver disease in Western countries, due in large part to its association with type 2 diabetes and obesity. The more advanced form of this disease is known as nonalcoholic steatohepatitis (NASH). If left untreated, NASH can evolve to cirrhosis, the late stage of fibrosis. Once cirrhosis is established, patients are at increased risk of developing gastrointestinal bleeding, liver cancer and liver failure that may require transplantation. A liver biopsy is currently needed to diagnose the severity of fatty liver disease but this is usually not indicated in asymptomatic patients. This procedure requires the insertion of a needle inside the liver to remove a small piece of tissue for examination under microscope. Liver biopsy is an invasive procedure with a small risk of major complications such as bleeding in 0.5% of cases. It is also affected by sub-optimal sampling leading to diagnostic errors
Ultrasound is optimum for screening patients with or without symptoms because it is a safe and widely available technology to scan the whole liver. Members of our team have developed Advanced ultrasound techniques that provide unique information not possible with state-of-the-art techniques. Unlike liver biopsy, these techniques would be applicable even in asymptomatic patients because it is non-invasive. This research proposal proposes a novel approach for diagnosis of NASH and will be the first study to measure individual components of NASH (fat, inflammation and fibrosis) with quantitative ultrasound (QUS) scores. This study is timely because NASH is the second leading cause of liver transplantation in North America and is predicted to become the leading indication in the near future.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Are at least 18 years old at screening;
Able to comprehend and willingness to provide voluntary consent;
Understand French or English;
Have a suspected or known NAFLD or NASH;
Disqualifiers
Are pregnant or trying to become pregnant;
Have a weight or girth preventing them from entering the MR magnet bore;
Are unable to understand or unwilling to provide written informed consent for this study;
Have risk factors for developing liver steatosis (type 2 diabetes mellitus, alcohol consumption >60g of alcohol per day, lipogenic medication and body mass index >25 kg/m2);
Trial population
The target population is adults with NAFLD or NASH and healthy volunteers (non-NAFLD subjects). For the purpose of this study, we will recruit NAFLD or NASH patients seen at the hepatology clinic of CHUM, a tertiary care center, and from the McGill University Health Centre (MUHC). Non-NAFLD volunteers will be recruited at the CHUM among the personnel.
Trial design
Case-only
Cross-sectional
Treatments tested in this trial
Acoustic radiation force impulse (ARFI), magnetic resonance elastography (MRE)
DeviceAcoustic Radiation Force Impulse (ARFI), Magnetic Resonance Elastography (MRE)
Treatment groups
Trial outcomes
Primary outcomes
Fibrosis stage
Measure of fibrosis stage using histology
Secondary outcomes
Liver stiffness determined by ARFI
Measure of liver stiffness using Acoustic Radiation Force Impulse (ARFI)-determined liver stiffness
Liver stiffness determined by MRE
Measure agnetic Resonance Elastography (MRE)-determined
Magnetic Resonance Imaging (MRI)-based Proton Density Fat Fraction (PDFF)
Staging liver fibrosis
Measure of staging liver fibrosis using magnetic Resonance Imaging (MRI) cine-tagging of cardiac-induced motion
Sponsors and contacts
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Centre hospitalier de l'Université de Montréal (CHUM)
Lead sponsor
McGill University Health Centre/Research Institute of the McGill University Health Centre
Collaborator
Canadian Institutes of Health Research (CIHR)
Collaborator
Centre de Recherche du Centre Hospitalier de l'Université de Montréal
Collaborator