Actively Recruiting

Age: 18Years +
All Genders
Healthy Volunteers
NCT03572465

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

331 weeks

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 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.

CONDITIONS

Official Title

Quantitative Ultrasound Techniques for Diagnosis of Nonalcoholic Steatohepatitis

Who Can Participate

Age: 18Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • At least 18 years old at screening
  • Able to understand and willing to provide voluntary consent
  • Understands French or English
  • For NAFLD/NASH subjects: suspected or known NAFLD or NASH and undergoing liver biopsy as part of clinical care
  • For non-NAFLD volunteers: no suspected or known NAFLD or NASH
Not Eligible

You will not qualify if you...

  • Pregnant or trying to become pregnant
  • Weight or body size prevents entering MR magnet bore
  • Unable or unwilling to provide written informed consent
  • For non-NAFLD volunteers: risk factors for liver steatosis (type 2 diabetes, alcohol consumption >60g/day, lipogenic medication, BMI >25 kg/m2)
  • For non-NAFLD volunteers: presence of liver steatosis (MRI-proton density fat fraction <5%)
  • For NAFLD/NASH subjects: other causes of chronic liver disease
  • For NAFLD/NASH subjects: history of liver transplantation

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 1 location

1

Centre Hospitalier de l'Université de Montréal

Montreal, Quebec, Canada, H2X 0A9

Actively Recruiting

Loading map...

Research Team

A

An Tang, MD, MSc

CONTACT

A

Assia Belblidia

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

2

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