Actively Recruiting
Quantitative Ultrasound Techniques for Diagnosis of Nonalcoholic Steatohepatitis
Led by Centre hospitalier de l'Université de Montréal (CHUM) · Updated on 2025-03-18
102
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
C
Centre hospitalier de l'Université de Montréal (CHUM)
Lead Sponsor
M
McGill University Health Centre/Research Institute of the McGill University Health Centre
Collaborating Sponsor
AI-Summary
What this Trial Is About
Nonalcoholic fatty liver disease (NAFLD) is the most common liver disease in Western countries, often linked to type 2 diabetes and obesity. Its advanced form, nonalcoholic steatohepatitis (NASH), can progress to serious liver damage, including fibrosis, cirrhosis, liver cancer, and liver failure. Currently, liver biopsy is the standard method to diagnose NASH severity, but it is invasive and carries risks, making it unsuitable for widespread screening, especially in patients without symptoms. This research explores new, non-invasive ultrasound techniques that could improve diagnosis and monitoring of NASH with less risk and greater accessibility. The study evaluates advanced quantitative ultrasound (QUS) techniques alongside magnetic resonance elastography (MRE) in adults with known or suspected NAFLD or NASH, as well as in non-obese volunteers without these conditions. All participants will undergo Acoustic Radiation Force Impulse (ARFI) and MRE imaging. These techniques aim to measure liver fat, inflammation, and fibrosis levels without the need for invasive biopsy. The study design is observational and includes both patients undergoing liver biopsy for clinical reasons and healthy volunteers. Participants will be assessed through imaging tests close in time to their liver biopsy if applicable. The primary outcome is to determine fibrosis stage within six weeks of biopsy. Secondary outcomes include liver stiffness measurements by ARFI and MRE and fat quantification by MRI. The study monitors diagnostic accuracy using these imaging methods compared to biopsy results. Participation involves imaging procedures and consent, with data analyzed to improve non-invasive diagnosis of NASH and potentially reduce the need for biopsies in the future.
CONDITIONS
Brief Title
Quantitative Ultrasound Techniques for Diagnosis of Nonalcoholic Steatohepatitis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- At least 18 years old at screening
- Able to understand and willing to provide voluntary consent
- Able to understand French or English
- NAFLD/NASH patients must have suspected or known NAFLD or NASH
- NAFLD/NASH patients must be undergoing a liver biopsy as part of clinical care
- Non-NAFLD volunteers must not have suspected or known NAFLD or NASH
You will not qualify if you...
- Pregnant or trying to become pregnant
- Weight or body size preventing entry into the MRI machine
- Unable or unwilling to provide informed consent
- Non-NAFLD volunteers with risk factors for liver steatosis including type 2 diabetes, high alcohol intake (>60g/day), lipogenic medication, or BMI over 25
- Non-NAFLD volunteers with liver steatosis defined by MRI-proton density fat fraction less than 5%
- NAFLD/NASH patients with other chronic liver diseases
- NAFLD/NASH patients with a liver transplant
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Within 6 weeks of liver biopsy
Participants undergo advanced ultrasound and magnetic resonance imaging techniques in close temporal proximity to a liver biopsy to evaluate liver tissue characteristics.
1 to 2 visits depending on scheduling of imaging and biopsy
Duration - Up to 6 weeks after liver biopsy
Participants are observed to assess disease status and progression after diagnostic procedures.
Follow-up assessments may occur depending on clinical care
Trial Site Locations
Total: 1 location
1
Centre Hospitalier de l'Université de Montréal
Montreal, Quebec, Canada, H2X 0A9
Actively Recruiting
Research Team
A
An Tang, MD, MSc
A
Assia Belblidia
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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