Quantitative Ultrasound Techniques for Diagnosis of Nonalcoholic Steatohepatitis
Recruiting · NCT03572465 · Observational (researchers observe without assigning treatment) · Lead sponsor: Centre hospitalier de l'Université de Montréal (CHUM)
View the official record on ClinicalTrials.gov →Interventions studied
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.
Who can take part
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 is running
1 location listed.
- Centre Hospitalier de l'Université de Montréal - Montreal, Quebec, Canada