Quantitative Ultrasound Techniques for Diagnosis of Nonalcoholic Steatohepatitis
QUS in NASH
1 other identifier
observational
102
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Oct 2019
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 19, 2018
CompletedFirst Posted
Study publicly available on registry
June 28, 2018
CompletedStudy Start
First participant enrolled
October 23, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 28, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
February 28, 2026
CompletedMarch 18, 2025
March 1, 2025
6.4 years
June 19, 2018
March 14, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Fibrosis stage
Measure of fibrosis stage using histology
Within 6 weeks of liver biopsy
Secondary Outcomes (4)
Liver stiffness determined by ARFI
Within 6 weeks of liver biopsy
Liver stiffness determined by MRE
Within 6 weeks of liver biopsy
Magnetic Resonance Imaging (MRI)-based Proton Density Fat Fraction (PDFF)
Within 6 weeks of liver biopsy
Staging liver fibrosis
Within 6 weeks of liver biopsy
Study Arms (2)
NAFLD, NASH patients
All patients enrolled will undergo: * Acoustic Radiation Force Impulse (ARFI) * Magnetic Resonance Elastography (MRE)
Non-obese volunteers
All patients enrolled will undergo: * Acoustic Radiation Force Impulse (ARFI) * Magnetic Resonance Elastography (MRE)
Interventions
Acoustic Radiation Force Impulse (ARFI), Magnetic Resonance Elastography (MRE)
Eligibility Criteria
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.
You may qualify if:
- Are at least 18 years old at screening;
- Able to comprehend and willingness to provide voluntary consent;
- Understand French or English;
- NAFLD/NASH subjects:
- Have a suspected or known NAFLD or NASH;
- Must undergo a liver biopsy as part of their clinical standard of care
- Non-NAFLD volunteers:
- Do not have a suspected or known NAFLD or NASH
You may not qualify if:
- 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;
- Non-NAFLD volunteers:
- 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);
- Have a liver steatosis (defined as MRI-proton density fat fraction \<5%);
- NAFLD/NASH subjects:
- Have other causes of chronic liver disease;
- Have a liver transplant
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Centre Hospitalier de l'Université de Montréal
Montreal, Quebec, H2X 0A9, Canada
Biospecimen
Liver biopsy specimens
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
An Tang, MD, MSc
Centre hospitalier de l'Université de Montréal (CHUM)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 19, 2018
First Posted
June 28, 2018
Study Start
October 23, 2019
Primary Completion
February 28, 2026
Study Completion
February 28, 2026
Last Updated
March 18, 2025
Record last verified: 2025-03