An observational study in Nonalcoholic Fatty Liver Disease (NAFLD) and Nonalcoholic Steatohepatitis (NASH), sponsored by Centre hospitalier de l'Université de Montréal (CHUM). Recruiting at 1 site in Canada. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-16.
Sponsored by Centre hospitalier de l'Université de Montréal (CHUM) · Observational
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.
BACKGROUND - Nonalcoholic fatty liver disease (NAFLD) is the most prevalent liver disease in Western countries. The more advanced form, nonalcoholic steatohepatitis (NASH) may evolve to fibrosis, cirrhosis, liver failure and liver cancer. Liver biopsy is the current reference standard for diagnosis of NASH. However, its invasiveness prevent its use for large-scale screening and diagnosis. Members of our team have developed innovative quantitative ultrasound (QUS) techniques (shear wave viscoelastography and sub-resolution cellular imaging) that have a high diagnostic potential. Advantages over magnetic resonance (MR) include the ability to characterize viscosity, cellular organizations and cost-effectiveness. We hypothesize that a combination of QUS techniques offering complementary assessment of tissue characteristics will differentiate NASH from NAFLD and quantify evolving grades of liver fat, inflammation and fibrosis.
OBJECTIVES - Primary objective: 1) Determine the accuracy of QUS parameters for diagnosis of NASH. Secondary objectives: 2) Determine the diagnostic accuracy of QUS for grading histology-determined liver fat, inflammation and fibrosis. 3) Compare the diagnostic accuracy of QUS and MR techniques for liver fat quantification.
Hypotheses: We hypothesize that QUS methods, including viscoelasticity, homodyned-K parameters and attenuation parameters can characterize properties of tissues encountered in NASH (including liver fat, inflammation and fibrosis).
METHODOLOGY - Design: This will be a cross-sectional imaging trial to evaluate the diagnostic accuracy of QUS techniques in 10 non-obese volunteers and 92 patients, using histopathology as the reference standard for patients. Paired index tests QUS-based (mechanical and cellular parameters) and MR-based (mechanical parameters and relaxation times reflecting tissue content) techniques will be performed as research procedures in close temporal proximity to the reference test (liver biopsy).
Inclusion criteria: Consecutive adult patients with known or suspected NAFLD or NASH undergoing a liver biopsy for clinical indications.
Exclusion criteria: Contraindication to MR, refusal to participate, any other cause of chronic liver disease or prior liver transplantation.
Data analysis: Random forest classifier to develop a predictive model. Cross-validated receiver operating characteristic curve analysis, sensitivity and specificity to assess diagnostic accuracy.
RATIONALE AND IMPACT - NASH has become the second leading cause of liver transplantation in North America and is predicted to become the leading indication in the near future. While liver biopsy is the established reference standard for NASH diagnosis and MR constitutes a noninvasive alternative, they are both impractical for large-scale application. Thus, there is an urgent need to investigate non-invasive and cost-effective techniques for diagnosis of NASH. Our proposed QUS techniques are experimental and currently not available on clinical US systems. A major impact of this work, for patients and medical institutions, will be to lower the need for liver biopsy, the risk of complications and reduce the cost for NASH diagnosis while providing quantitative therapeutic targets.
1,617 studies on the registry are indexed under Non-alcoholic Fatty Liver Disease; 324 are open to participants now.
This study's planned enrollment of 102 is below the median of 153 across 390 observational studies indexed under Non-alcoholic Fatty Liver Disease.
Browse Non-alcoholic Fatty Liver Disease studies →Centre hospitalier de l'Université de Montréal (CHUM) is the lead sponsor of 376 studies on the registry; 110 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
NAFLD/NASH subjects:
Non-NAFLD volunteers:
Exclusion Criteria:
Non-NAFLD volunteers:
NAFLD/NASH subjects:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
All patients enrolled will undergo: * Acoustic Radiation Force Impulse (ARFI) * Magnetic Resonance Elastography (MRE)
Device: Acoustic radiation force impulse (ARFI), magnetic resonance elastography (MRE)
All patients enrolled will undergo: * Acoustic Radiation Force Impulse (ARFI) * Magnetic Resonance Elastography (MRE)
Device: Acoustic radiation force impulse (ARFI), magnetic resonance elastography (MRE)
Acoustic Radiation Force Impulse (ARFI), Magnetic Resonance Elastography (MRE)
Fibrosis stage
Measure of fibrosis stage using histology
Time frame: Within 6 weeks of liver biopsy
Liver stiffness determined by ARFI
Measure of liver stiffness using Acoustic Radiation Force Impulse (ARFI)-determined liver stiffness
Time frame: Within 6 weeks of liver biopsy
Liver stiffness determined by MRE
Measure agnetic Resonance Elastography (MRE)-determined
Time frame: Within 6 weeks of liver biopsy
Magnetic Resonance Imaging (MRI)-based Proton Density Fat Fraction (PDFF)
Time frame: Within 6 weeks of liver biopsy
Staging liver fibrosis
Measure of staging liver fibrosis using magnetic Resonance Imaging (MRI) cine-tagging of cardiac-induced motion
Time frame: Within 6 weeks of liver biopsy
Started Oct 2019 (actual). Primary completion is estimated for Oct 2026, 84 months after the start.
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