Clinical trial NCT04682600: The Sonic Incytes Liver Incytes System, Evaluation of Liver Fibrosis and Steatosis Versus MRE and MRI PDFF
Official title: The Sonic Incytes Liver Incytes System, Evaluation of Liver Fibrosis and Steatosis Versus MRE and MRI PDFF
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Non-Alcoholic Fatty Liver Disease (NAFLD)
Non-Alcoholic Steatohepatitis (NASH)
Liver Fibroses
Liver Steatoses
Keywords: NASH
NAFL
NAKLD
Liver
Elastography
Ultrasound
Lead sponsor: Sonic Incytes
Sponsor class: INDUSTRY
First posted: 2020-12-24
Enrollment: 164
Sex: ALL
Minimum age (years): 19
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The main purpose of this study is to compare the effectiveness of various non-invasive elastography techniques at determining liver stiffness measures in human subjects. Specifically, the investigators are comparing MRE and FibroScan to Vibroelastography (VE, Liver Incytes System). These techniques are used to measure stiffness in the liver.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Elasticity measurements comparison between Liver Incytes MR Elastography
timeFrame: 12 months
measure: Determination of Liver Incytes' discriminatory ability of liver stiffness as measured by fibrosis staging
timeFrame: 12 months
Secondary outcomes:
measure: Attenuation measurements comparison between the Liver incytes System and MRI Proton Density Fat Fraction
timeFrame: 12 months
measure: Comparison between Liver Incytes' and FibroScan's fibrosis staging capabilities
timeFrame: 12 months
measure: Comparison between Liver Incytes' and FibroScan's steatosis staging capabilities
timeFrame: 12 months
measure: Incidence of and Device Deficiencies
timeFrame: 12 months
measure: Incidence of Adverse Events
timeFrame: 12 Months
Other outcomes:
measure: Identification of cases in which FibroScan may overestimate or underestimate liver stiffness
timeFrame: 12 months
measure: Identification of cases in which FibroScan may overestimate or underestimate fat content
timeFrame: 12 months
measure: Liver Incytes System User Experience Survey
timeFrame: 12 months
measure: Liver Incytes System Inter-user Elasticity Variability
timeFrame: 12 months
measure: Liver Incytes System Inter-user Attenuation Variability
timeFrame: 12 months
measure: Liver Incytes System Intra-Subject Variability
timeFrame: 12 months
Locations:
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Centre
state: Massachusetts
Study officials:
References: