Using ultrasound techniques to diagnose nonalcoholic steatohepatitis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to evaluate the accuracy of innovative quantitative ultrasound (QUS) techniques for diagnosing nonalcoholic steatohepatitis (NASH) in patients with nonalcoholic fatty liver disease (NAFLD). The study will compare the diagnostic capabilities of QUS methods, such as shear wave viscoelastography, with traditional liver biopsy and magnetic resonance elastography. By assessing tissue characteristics like viscosity and cellular organization, the researchers hope to provide a non-invasive alternative for diagnosing and grading liver conditions. Participants will include both NAFLD/NASH patients undergoing liver biopsy and healthy volunteers.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Where it's running

• Centre Hospitalier de l'Université de Montréal
  Montreal, Quebec, Canada Recruiting

Study contacts

• Study coordinator: An Tang, MD, MSc
• Email: an.tang@umontreal.ca
• Phone: 514-890-8000

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.