NCT04682600

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 164 (actual)
• Sponsor: Sonic Incytes · Industry
• Sex: All
• Age: 19 Years – 75 Years
• Healthy volunteers: Accepted

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.

Conditions

• Non-Alcoholic Fatty Liver Disease (NAFLD)
• Non-Alcoholic Steatohepatitis (NASH)
• Liver Fibroses
• Liver Steatoses

Interventions

Type	Name	Description
DEVICE	Liver Incytes System	The Liver Incytes System uses the Shear Wave Absolute Vibro-Elastrography (S-WAVE) method. The imaging procedure of the Liver Incytes system is similar to a traditional ultrasound scanning procedure or FibroScan, in which the patient is asked to lie supine on an examination bed, with the operator seated next to them. A vibration source is placed under the patient, between the patient and the bed to induce shear waves in the liver. Ultrasound imaging through the patient ribs is used to track the displacements of these waves. Through tracking of the displacements, the shear wave velocity and tissue stiffness can be calculated. The use of volumetric multi-frequency imaging increases the amount of liver scanned

Timeline

• Start date: 2020-10-21
• Primary completion: 2022-11-01
• Completion: 2023-07-01
• First posted: 2020-12-24
• Last updated: 2022-12-09

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study