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Quantitative Ultrasound Techniques for Diagnosis of Nonalcoholic Steatohepatitis

Recruitingn/aAges 18 Years - anyAllCentre hospitalier de l'Université de Montréal (C…
NCT03572465 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 affec

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📋 Eligibility rules (as published)
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
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What it tests

  • Acoustic radiation force impulse (ARFI), magnetic resonance elastography (MRE)
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Where

1 site
Centre Hospitalier de l'Université de Montréal
Montreal, Canada
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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