The Sonic Incytes Liver Incytes System, Evaluation of Liver Fibrosis and Steatosis Versus MRE and MRI PDFF
NCT ID: NCT04682600
Last Updated: 2022-12-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
164 participants
INTERVENTIONAL
2020-10-21
2023-07-01
Brief Summary
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Detailed Description
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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
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Keywords
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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Open-label
Volunteers who have agreed to participate in the study will have their liver scanned using the FibroScan, VE (Liver Incytes System) and MRE techniques.
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
Interventions
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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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
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
19 Years
75 Years
ALL
Yes
Sponsors
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Sonic Incytes
INDUSTRY
Responsible Party
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Locations
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Beth Israel Deaconess Medical Centre
Boston, Massachusetts, United States
Countries
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Other Identifiers
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SI-CLIN-02
Identifier Type: -
Identifier Source: org_study_id