Using ultrasound techniques to diagnose nonalcoholic steatohepatitis
Quantitative Ultrasound Techniques for Diagnosis of Nonalcoholic Steatohepatitis
This study is testing new ultrasound techniques to see if they can accurately diagnose nonalcoholic steatohepatitis in people with fatty liver disease without needing a liver biopsy.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 102 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Centre hospitalier de l'Université de Montréal (CHUM) Academic / other |
| Locations | 1 site (Montreal, Quebec) |
| Trial ID | NCT03572465 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with suspected or known NAFLD or NASH who are scheduled for a liver biopsy.
Not a fit: Patients with other causes of chronic liver disease or those who have had a liver transplant may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a safer, non-invasive method for diagnosing and monitoring liver disease progression in patients.
How similar studies have performed: Other studies have shown promise in using ultrasound techniques for liver disease diagnosis, but this specific approach is innovative and not widely tested.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Montreal, Quebec
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.