Quantitative Ultrasound Techniques for Diagnosis of Nonalcoholic Steatohepatitis

Launched by CENTRE HOSPITALIER DE L'UNIVERSITÉ DE MONTRÉAL (CHUM) · Jun 19, 2018

Keywords

ClinConnect Summary

This clinical trial is studying new ultrasound techniques to diagnose a liver condition called nonalcoholic steatohepatitis (NASH), which is a more serious form of nonalcoholic fatty liver disease (NAFLD). NASH can lead to severe liver problems, including cirrhosis and liver failure, if not managed properly. Currently, a liver biopsy—an invasive procedure where a small tissue sample is taken from the liver—is needed for diagnosis, but this study aims to use advanced ultrasound methods that are safer and non-invasive. These techniques can assess different aspects of NASH, like fat buildup and inflammation, without needing to put patients through the risks associated with a biopsy.

To participate in the trial, individuals must be at least 18 years old and either have suspected or known NAFLD/NASH or be healthy volunteers without liver issues. Participants will undergo both a liver biopsy and an MRI to help researchers gather data. The study is important because NASH is becoming a leading cause of liver transplants in North America, and finding safer ways to diagnose it could help many patients in the future. If you’re considering participation, you can expect a supportive environment where your health and safety are top priorities.

Gender

ALL

Eligibility 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