Development of a Quantifiable Ultrasound Biomarker for Hepatic Steatosis

NCT07270601 | Recruiting FDA Device

• 1 other identifier: COV-POCUS-001
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

MASLD - Metabolic Dysfunction-Associated Steatotic Liver Disease; NAFLD - Non-Alcoholic Fatty Liver Disease

Keywords

MASLD; NAFLD; Ultrasound; Steatosis; Fibrosis; MRI-PDFF

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Individual Ultrasound parameter vs. MRI-PDFF

  1 year

• Ultrasound Shear Wave vs MR Elastography

  1 year

Study Arms (1)

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.

Device: Verasonics NXT Data Acquisition System; Device: Philips EPIQ Elite; Device: EchoSense FibroScan; Device: Philips 3T Ingenia Elition

Interventions

Verasonics NXT Data Acquisition System DEVICE

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

Cohort

Philips EPIQ Elite DEVICE

A premium ultrasound system with software package to support imaging research studies.

Cohort

EchoSense FibroScan DEVICE

A non-invasive ultrasound solution that accurately measures liver stiffness and liver steatosis.

Cohort

Philips 3T Ingenia Elition DEVICE

A 3-tesla magnetic resonance imaging (MRI) system

Cohort

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.)

You may not qualify if:

• 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

Sponsors & Collaborators

• ContextVision AB: lead
• University of Washington: collaborator

Study Sites (1)

University of Washington

Seattle, Washington, 98195, United States

RECRUITING

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease; Fatty Liver; Fibrosis

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Laura Sissons-Ross Research Manager

CONTACT

206-616-0397; lsissons@uw.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 19, 2025
• First Posted: December 8, 2025
• Study Start: November 17, 2025
• Primary Completion (Estimated): October 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: December 8, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)