Non-Alcoholic Fatty Liver Disease (NAFLD)NCT04682600
The Sonic Incytes Liver Incytes System, Evaluation of Liver Fibrosis and Steatosis Versus MRE and MRI PDFF
A study testing Liver Incytes System in people with Non-Alcoholic Fatty Liver Disease (NAFLD) and Non-Alcoholic Steatohepatitis (NASH), run by Sonic Incytes at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 19 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Non-Alcoholic Fatty Liver Disease (NAFLD), Non-Alcoholic Steatohepatitis (NASH), Liver Fibroses
- What is being tested?
- Liver Incytes System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 164 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Oct 2020to 1 Jul 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- Active viral hepatitis
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Beth Israel Deaconess Medical Centre
Boston, Massachusetts, 02215
About this study
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.
Read the 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
- Being tested
- Liver Incytes System
- Keywords
- NASH, NAFL, NAKLD, Liver, Elastography, Ultrasound
- Medical subject headings
- Non-alcoholic Fatty Liver Disease, Liver Cirrhosis, Fatty Liver
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Liver Incytes SystemDevice
Also called MRE, MRI PDFF, Fibroscan
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
| Study group | Role | What they receive |
|---|---|---|
| Open-label | Experimental | Volunteers who have agreed to participate in the study will have their liver scanned using the FibroScan, VE (Liver Incytes System) and MRE techniques. Receives: Device: Liver Incytes System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Elasticity measurements comparison between Liver Incytes MR Elastography
Elasticity measurements (kPa) from the Liver Incytes system and the MR system will be compared to determined whether the reported stiffness of the tissue (mean and 95% confidence intervals) are equivalent by concordance correlation coefficient and 95% confidence intervals.
Measured: 12 months
Determination of Liver Incytes' discriminatory ability of liver stiffness as measured by fibrosis staging
Liver Incytes liver stiffness values will be compared to values obtained using MRE to determine the cutoff values for the Liver Incytes System for each level of fibrosis staging. For each stage of fibrosis as defined by MRE, Area Under the Receiver Operating Curve (AUROC) for Liver Incytes elasticity will be calculated and the cutoff maximizing the sensitivity and specificity will be determined.
Measured: 12 months
Secondary outcomes (5)
Attenuation measurements comparison between the Liver incytes System and MRI Proton Density Fat Fraction
Attenuation measurements (dB/m) from the Liver Incytes System and MRI proton density fat fraction will be compared to determine whether they are equivalent by concordance correlation coefficient and 95% confidence intervals
Measured: 12 months
Comparison between Liver Incytes' and FibroScan's fibrosis staging capabilities
Compare the discriminatory ability of Liver Incytes' and FibroScan's elasticity (kPa) measurements in determining different stages of fibrosis using MRE as gold standard.
For each stage of fibrosis, a Receiver Operating Curve will be constructed using the corresponding FibroScan measurements, and the Area Under the Receiver Operating Curve (AUROC) will be compared to the result from Liver Incytes.
Measured: 12 months
Comparison between Liver Incytes' and FibroScan's steatosis staging capabilities
Compare the discriminatory ability of Liver Incytes' and FibroScan's attenuation measurements (dB/m) in determining different stages of steatosis using MRE as gold standard.
For each stage of steatosis, a Receiver Operating Curve will be constructed using the corresponding FibroScan measurements, and the Area Under the Receiver Operating Curve (AUROC) will be compared to the result from Liver Incytes.
Measured: 12 months
Incidence of and Device Deficiencies
The frequency of device deficiencies and failures will be described based on events reported
Measured: 12 months
Incidence of Adverse Events
Descriptive statistics including frequency and severity of all reported adverse events.
Measured: 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2020
- Study start21 Oct 2020
- Primary completion1 Nov 2022
- Study completion1 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Alcoholic Fatty Liver Disease (NAFLD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 164 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sonic Incytes
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04682600
- Sponsor's protocol ID
- SI-CLIN-02
- Status last verified
- Dec 2022
- First submitted
- 20 Oct 2020
- Last updated
- 20 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Sonic Incytes Liver Incytes System, Evaluation of Liver Fibrosis and Steatosis Versus MRE and MRI PDFF
- ClinicalTrials.gov ID
- NCT04682600
- Acronym / sponsor ID
- SI-CLIN-02
- Conditions
- Non-Alcoholic Fatty Liver Disease (NAFLD), Non-Alcoholic Steatohepatitis (NASH), Liver Fibroses, Liver Steatoses
- Keywords
- NASH, NAFL, NAKLD, Liver, Elastography, Ultrasound
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 164 participants (actual)
- Lead sponsor
- Sonic IncytesIndustry (pharma, biotech, devices)
- Study start
- 21 Oct 2020 (actual)
- Primary completion
- 1 Nov 2022 (actual)
- Study completion
- 1 Jul 2023 (actual)
- First posted
- 24 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Open-label | Experimental | Device: Liver Incytes SystemVolunteers who have agreed to participate in the study will have their liver scanned using the FibroScan, VE (Liver Incytes System) and MRE techniques. |
Who may qualify
- Ages
- 19 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (10 listed)
- Active viral hepatitis
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Liver Incytes SystemAlso: MRE, MRI PDFF, FibroscanThe 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 | Device | Open-label |
Primary outcome
Elasticity measurements comparison between Liver Incytes MR Elastography
Time frame: 12 months
Elasticity measurements (kPa) from the Liver Incytes system and the MR system will be compared to determined whether the reported stiffness of the tissue (mean and 95% confidence intervals) are equivalent by concordance correlation coefficient and 95% confidence intervals.
Determination of Liver Incytes' discriminatory ability of liver stiffness as measured by fibrosis staging
Time frame: 12 months
Liver Incytes liver stiffness values will be compared to values obtained using MRE to determine the cutoff values for the Liver Incytes System for each level of fibrosis staging. For each stage of fibrosis as defined by MRE, Area Under the Receiver Operating Curve (AUROC) for Liver Incytes elasticity will be calculated and the cutoff maximizing the sensitivity and specificity will be determined.
5 secondary outcomes
Attenuation measurements comparison between the Liver incytes System and MRI Proton Density Fat Fraction
Time frame: 12 months
Comparison between Liver Incytes' and FibroScan's fibrosis staging capabilities
Time frame: 12 months
Comparison between Liver Incytes' and FibroScan's steatosis staging capabilities
Time frame: 12 months
Incidence of and Device Deficiencies
Time frame: 12 months
Incidence of Adverse Events
Time frame: 12 Months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Liver Incytes System in people with Non-Alcoholic Fatty Liver Disease (NAFLD) and Non-Alcoholic Steatohepatitis (NASH), run by Sonic Incytes at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Elasticity measurements comparison between Liver Incytes MR Elastography (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2026.