Development of a Quantifiable Ultrasound Biomarker for Hepatic Steatosis (LYNX)

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.

Study Overview

• Status: Recruiting
• Conditions: NAFLD - Non-Alcoholic Fatty Liver Disease; MASLD - Metabolic Dysfunction-Associated Steatotic Liver Disease
• Intervention / Treatment: Device: Verasonics NXT Data Acquisition System; Device: Philips EPIQ Elite; Device: EchoSense FibroScan; Device: Philips 3T Ingenia Elition

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 Type: Interventional
• Enrollment (Estimated): 110
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Laura Sissons-Ross Research Manager; Phone Number: 206-616-0397; Email: lsissons@uw.edu

Study Locations

• United States
  • Washington
    • Seattle, Washington, United States, 98195
      • Recruiting
      • University of Washington
      • Contact: Research Fellow; Phone Number: 206-616-0397; Email: madhvi@uw.edu
      • Principal Investigator: Rotonya Carr, MD
      • Principal Investigator: Manish Dhyani, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

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:

• 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.)

Exclusion Criteria:

• 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.
• Presence of known congenital hepatic anomaly.
• Known cirrhosis
• Known active cancer

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Cohort; 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.

Device: Verasonics NXT Data Acquisition System; 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; Device: Philips EPIQ Elite; A premium ultrasound system with software package to support imaging research studies.; Device: EchoSense FibroScan; A non-invasive ultrasound solution that accurately measures liver stiffness and liver steatosis.; Device: Philips 3T Ingenia Elition; A 3-tesla magnetic resonance imaging (MRI) system

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Individual Ultrasound parameter vs. MRI-PDFF	Evaluation of each ultrasound parameter (backscatter, attenuation and speed of sound) fat percentage values separately against MRI-PDFF.	1 year
Ultrasound Shear Wave vs MR Elastography	Evaluation of ultrasound shear wave elastography-derived tissue stiffness values in kilopascals compared to MR elastography.	1 year

Collaborators and Investigators

• Sponsor: ContextVision AB
• Collaborators: University of Washington

Study record dates

Study Major Dates

• Study Start (Actual): November 17, 2025
• Primary Completion (Estimated): October 31, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: November 19, 2025
• First Submitted That Met QC Criteria: November 26, 2025
• First Posted (Actual): December 8, 2025

Study Record Updates

• Last Update Posted (Actual): December 8, 2025
• Last Update Submitted That Met QC Criteria: November 26, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: Ultrasound; Fibrosis; NAFLD; Steatosis; MRI-PDFF; MASLD
• Additional Relevant MeSH Terms: Pathologic Processes; Digestive System Diseases; Liver Diseases; Pathological Conditions, Signs and Symptoms; Fibrosis; Fatty Liver; Non-alcoholic Fatty Liver Disease
• Other Study ID Numbers: COV-POCUS-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No