The Sonic Incytes Liver Incytes System, Evaluation of Liver Fibrosis and Steatosis Versus MRE and MRI PDFF

The Liver Incytes system allows for full visualization of the liver with the low cost and portability of ultrasound. It is an adjustable multi-frequency technique, which can show large areas of the organ as volumetric elasticity maps. The device uses the Shear Wave Absolute Vibro-Elastography (S-WAVE) method.

The primary objective of the study is to determine the relationship between the elasticity results from Liver Incytes and those of MR Elastography. In addition to stiffness measurements, the relationship between the Liver Incytes attenuation measurements and MR-PDFF will also be evaluated.

As secondary objectives, the ability of Liver Incytes to correctly stage patients using MRE as the standard (unless biopsy is available), looking specifically at the ability to measure mild and advanced fibrosis.

In additional to performance objectives, the safety, tolerability and usability of the device will be assessed.

This is a prospective, open label, validation study of the Liver Incytes system in comparison to MR results (as gold standard) in patients with liver disease or suspected liver disease. Approximately 100 subjects may be enrolled in this study which will take place at clinical centers across Canada and the United States. Study participants should be distributed primarily across the 4 stages of fibrosis, with secondary consideration of the three stages of steatosis.

The study is comprised of: Screening Period (up to 28 days) and Data Collection Period. There are no safety follow-up visits in this study.

• Screening Period (-28 days to Prior to Imaging (Fibroscan, Liver Incytes, MRE)): during the screening phase, participants will provide written informed consent before undergoing procedures to determine study eligibility.
• Data Collection Period (variable duration): Study participants will attend a study visit on Day 1 and may attend an optional visit within 28 days of the initial/Day 1 visit.

The total duration of study participation will vary from approximately 2 weeks to approximately 8 weeks.

Inclusion criteria

• Adults, 19-75 years old
• Healthy volunteers or Patients with evidence of NAFLD such as one of the following:

Previous liver biopsy consistent with NAFLD OR

Evidence of hepatic steatosis on non-invasive assessment by one or more of the following criteria:

• Abdominal ultrasound within 12 months
• MRI-PDFF (greater than 12%) within 12 month
• FibroScan CAP score > 230 dB/m within 12 months OR At least 2 criteria for metabolic syndrome and increased stiffness on FibroScan (>8kPa) within 12 months
• Able to understand the informed consent form, study procedures and willing to participate in study
• If female and of child bearing potential, must agree to practice a highly effective contraception method.

Exclusion criteria

• Active viral hepatitis

a. Patients with cured HCV (those with history of treatment and have Sustained Viral Response for 12 weeks (SVR12)) or controlled HBV with no viral detected for more than 6 months are eligible

• Decompensated cirrhosis (history of ascites, encephalopathy, or variceal bleeding)
• ALT or AST > 5 x ULN on historical blood work within the past 3 months
• BMI greater than 40 kg/m2 (or using cutoff based on MRI)
• Other known causes of chronic liver disease
• Individuals with history of persistent ethanol abuse (alcohol consumption > 20g etoh/day for women, > 40 g etoh/day for men)
• Individuals with surgically removed gallbladder
• Pregnant or planning to become pregnant while enrolled in this study
• Other conditions which would exclude patients from entering an MRI