MASLD - Metabolic Dysfunction-Associated Steatotic Liver DiseaseLYNXNCT07270601
Development of a Quantifiable Ultrasound Biomarker for Hepatic Steatosis
A study testing Verasonics NXT Data Acquisition System, Philips EPIQ Elite and EchoSense FibroScan in people with MASLD - Metabolic Dysfunction-Associated Steatotic Liver Disease and NAFLD - Non-Alcoholic Fatty Liver Disease, run by ContextVision AB at 1 site in United States.
Trial summary
The research study is considering a non-invasive way to measure the percentage of fat in the liver using ultrasound. This could help detect early signs of a very common condition called metabolic dysfunction-associated steatotic liver disease (MASLD). Current tests, like MRI or biopsy, can be expensive or invasive. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- MASLD - Metabolic Dysfunction-Associated Steatotic Liver Disease, NAFLD - Non-Alcoholic Fatty Liver Disease
- What is being tested?
- Verasonics NXT Data Acquisition System, Philips EPIQ Elite and EchoSense FibroScan
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Nov 2025to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Diseased subject:
- Adult patients (age 18 - 75 years)
- Consent to participate in the study
- Diagnosed or suspected MASLD from the hepatology clinic, OR
- High-risk population meeting the adult cardiometabolic criteria (defined as the presence of at least one of the following: diabetes, obesity (BMI ≥ 25 kg/m2), hypercholesterolemia, and hypertension)
- Healthy volunteer:
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- Adult patients (age 18 - 75 years)
- Consent to participate in the study
- No suspicion of MASLD by laboratory/imaging/clinical examinations
- Absence of known pre-existing conditions (metabolic syndrome, diabetes mellitus, obesity, insulin resistance, dyslipidemia, etc.)
Who cannot join
- Pregnancy or nursing.
- Contraindications to MRI including, but not limited to, severe claustrophobia, pacemaker, or existing metallic/mechanical implant(s).
- Acute illness/cognitive impairment resulting in an inability to cooperate with the MRI and ultrasound breath-holding instructions.
- BMI > 35 kg/m2
- History of excessive alcohol consumption according to the updated MASLD criteria (>2 drinks/day OR >210 grams/week for males AND >1 drink/day OR >140 grams/week for females) or drug use over the past 2 years.
- Known acute or chronic hepatitis; or other etiology of liver disease.
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- Presence of known congenital hepatic anomaly.
- Known cirrhosis
- Known active cancer
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Washington
Seattle, Washington, 98195
Research Fellow, 206-616-0397, madhvi@uw.edu
Rotonya Carr, MD
About this study
Official title: Development and Diagnostic Evaluation of a Novel Quantifiable Ultrasound Based Multi-parametric Biomarker for Hepatic Steatosis in Patients With Suspected MASLD ( LYNX )
The research study is considering a non-invasive way to measure the percentage of fat in the liver using ultrasound. This could help detect early signs of a very common condition called metabolic dysfunction-associated steatotic liver disease (MASLD). Current tests, like MRI or biopsy, can be expensive or invasive. If successful, this ultrasound tool could become an easier and more accessible way to monitor liver health - especially for people with obesity, diabetes, high blood pressure, or high cholesterol.
Read the detailed description
The objective is to develop a novel multiparametric ultrasound-based technique to quantify the amount of steatosis in the liver by using the current MRI-based gold-standard - MRI proton density fat fraction (MRI-PDFF) as a clinical reference. This clinical development study will only collect the required dataset from healthy volunteers and subjects with different degrees of steatosis in the liver, particularly patients with MASLD, formerly non-alcoholic fatty liver disease (NAFLD). It will capture the raw radiofrequency data required for the development of this new radiologic biomarker on a research ultrasound imaging device. In addition, various other clinical and radiological datasets will be captured to support the ground truthing, development and training of the novel ultrasound-based multiparametric biomarker.
- Conditions
- MASLD - Metabolic Dysfunction-Associated Steatotic Liver Disease, NAFLD - Non-Alcoholic Fatty Liver Disease
- Being tested
- Verasonics NXT Data Acquisition System, Philips EPIQ Elite, EchoSense FibroScan, Philips 3T Ingenia Elition
- Keywords
- MASLD, NAFLD, Ultrasound, Steatosis, Fibrosis, MRI-PDFF
- Medical subject headings
- Non-alcoholic Fatty Liver Disease, Fatty Liver, Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Verasonics NXT Data Acquisition SystemDevice
A research ultrasound imaging device to capture raw radiofrequency ultrasound data for the following parameters:
- B-mode imaging
- Attenuation coefficient
- Backscatter coefficient
- Speed of sound
- Shear wave elastography
Philips EPIQ EliteDevice
A premium ultrasound system with software package to support imaging research studies.
EchoSense FibroScanDevice
A non-invasive ultrasound solution that accurately measures liver stiffness and liver steatosis.
Philips 3T Ingenia ElitionDevice
A 3-tesla magnetic resonance imaging (MRI) system
| Study group | Role | What they receive |
|---|---|---|
| Cohort | Experimental | Adult healthy volunteers as well as subjects who have a diagnosis, or suspected, of having MASLD or are deemed to meet the high-risk cardiometabolic criteria. Receives: Device: Verasonics NXT Data Acquisition System; Device: Philips EPIQ Elite; Device: EchoSense FibroScan; Device: Philips 3T Ingenia Elition |
What is being measured
The primary outcome is the main question the study is designed to answer.
Multiparametric Ultrasound Biomarker vs. MR-PDFF
Clinical qualification of the multiparametric ultrasound-derived fat fraction, defined as its agreement with the established clinical reference, MRI proton density fat fraction (MRI-PDFF) expressed as absolute percentage, in bench testing analysis.
Measured: 1 year
Secondary outcomes (2)
Individual Ultrasound parameter vs. MRI-PDFF
Evaluation of each ultrasound parameter (backscatter, attenuation and speed of sound) fat percentage values separately against MRI-PDFF.
Measured: 1 year
Ultrasound Shear Wave vs MR Elastography
Evaluation of ultrasound shear wave elastography-derived tissue stiffness values in kilopascals compared to MR elastography.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2025
- Study start17 Nov 2025
- Primary completion31 Oct 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MASLD - Metabolic Dysfunction-Associated Steatotic Liver DiseaseStudies 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
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ContextVision AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Washington
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07270601
- Sponsor's protocol ID
- COV-POCUS-001
- Acronym
- LYNX
- Status last verified
- Nov 2025
- First submitted
- 19 Nov 2025
- Last updated
- 8 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Diagnostic Evaluation of a Novel Quantifiable Ultrasound Based Multi-parametric Biomarker for Hepatic Steatosis in Patients With Suspected MASLD ( LYNX )
- ClinicalTrials.gov ID
- NCT07270601
- Acronym / sponsor ID
- LYNX / COV-POCUS-001
- Conditions
- MASLD - Metabolic Dysfunction-Associated Steatotic Liver Disease, NAFLD - Non-Alcoholic Fatty Liver Disease
- Keywords
- MASLD, NAFLD, Ultrasound, Steatosis, Fibrosis, MRI-PDFF
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- ContextVision ABIndustry (pharma, biotech, devices)
- Collaborators
- University of Washington
- Study start
- 17 Nov 2025 (actual)
- Primary completion
- 31 Oct 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 8 Dec 2025 (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 research study is considering a non-invasive way to measure the percentage of fat in the liver using ultrasound. This could help detect early signs of a very common condition called metabolic dysfunction-associated steatotic liver disease (MASLD). Current tests, like MRI or biopsy, can be expensive or invasive. If successful, this ultrasound tool could become an easier and more accessible way to monitor liver health - especially for people with obesity, diabetes, high blood pressure, or high cholesterol.
Detailed description
The objective is to develop a novel multiparametric ultrasound-based technique to quantify the amount of steatosis in the liver by using the current MRI-based gold-standard - MRI proton density fat fraction (MRI-PDFF) as a clinical reference. This clinical development study will only collect the required dataset from healthy volunteers and subjects with different degrees of steatosis in the liver, particularly patients with MASLD, formerly non-alcoholic fatty liver disease (NAFLD). It will capture the raw radiofrequency data required for the development of this new radiologic biomarker on a research ultrasound imaging device. In addition, various other clinical and radiological datasets will be captured to support the ground truthing, development and training of the novel ultrasound-based multiparametric biomarker.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cohort | Experimental | Device: Verasonics NXT Data Acquisition System, Device: Philips EPIQ Elite, Device: EchoSense FibroScan, Device: Philips 3T Ingenia ElitionAdult healthy volunteers as well as subjects who have a diagnosis, or suspected, of having MASLD or are deemed to meet the high-risk cardiometabolic criteria. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Adult patients (age 18 - 75 years)
- Consent to participate in the study
- Diagnosed or suspected MASLD from the hepatology clinic, OR
- High-risk population meeting the adult cardiometabolic criteria (defined as the presence of at least one of the following: diabetes, obesity (BMI ≥ 25 kg/m2), hypercholesterolemia, and hypertension)
- Adult patients (age 18 - 75 years)
Key exclusion criteria (9 listed)
- Pregnancy or nursing.
- Contraindications to MRI including, but not limited to, severe claustrophobia, pacemaker, or existing metallic/mechanical implant(s).
- Acute illness/cognitive impairment resulting in an inability to cooperate with the MRI and ultrasound breath-holding instructions.
- BMI > 35 kg/m2
- History of excessive alcohol consumption according to the updated MASLD criteria (>2 drinks/day OR >210 grams/week for males AND >1 drink/day OR >140 grams/week for females) or drug use over the past 2 years.
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 |
|---|---|---|
| Verasonics NXT Data Acquisition SystemA research ultrasound imaging device to capture raw radiofrequency ultrasound data for the following parameters: * B-mode imaging * Attenuation coefficient * Backscatter coefficient * Speed of sound * Shear wave elastography | Device | Cohort |
| Philips EPIQ EliteA premium ultrasound system with software package to support imaging research studies. | Device | Cohort |
| EchoSense FibroScanA non-invasive ultrasound solution that accurately measures liver stiffness and liver steatosis. | Device | Cohort |
| Philips 3T Ingenia ElitionA 3-tesla magnetic resonance imaging (MRI) system | Device | Cohort |
Primary outcome
Multiparametric Ultrasound Biomarker vs. MR-PDFF
Time frame: 1 year
Clinical qualification of the multiparametric ultrasound-derived fat fraction, defined as its agreement with the established clinical reference, MRI proton density fat fraction (MRI-PDFF) expressed as absolute percentage, in bench testing analysis.
2 secondary outcomes
Individual Ultrasound parameter vs. MRI-PDFF
Time frame: 1 year
Ultrasound Shear Wave vs MR Elastography
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2025.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Verasonics NXT Data Acquisition System, Philips EPIQ Elite and EchoSense FibroScan in people with MASLD - Metabolic Dysfunction-Associated Steatotic Liver Disease and NAFLD - Non-Alcoholic Fatty Liver Disease, run by ContextVision AB 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 10 inclusion and 9 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: looking for participants now, as of the sponsor's last update on 8 Dec 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Laura Sissons-Ross Research Manager (206-616-0397, lsissons@uw.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Multiparametric Ultrasound Biomarker vs. MR-PDFF (time frame: 1 year). 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 8 Dec 2025.