Development of a Quantifiable Ultrasound Biomarker for Hepatic Steatosis

Part of paid clinical trials in Seattle, Washington.

Sponsor
ContextVision AB
Study ID
NCT07270601
Status
Recruiting
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Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Accepted

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
  • Philips EPIQ Elite — DEVICE
    A premium ultrasound system with software package to support imaging research studies.
  • EchoSense FibroScan — DEVICE
    A non-invasive ultrasound solution that accurately measures liver stiffness and liver steatosis.
  • Philips 3T Ingenia Elition — DEVICE
    A 3-tesla magnetic resonance imaging (MRI) system

Study Details

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.

Key Dates

Start date
Nov 17, 2025
Status verified
Nov 2025
Primary completion
Oct 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
110 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC

Arms

  • 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.

Primary Outcome Measure

Multiparametric Ultrasound Biomarker vs. MR-PDFF [ Time Frame: 1 year ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of WashingtonSeattleWashington98195
Research Fellow
[email protected]
206-616-0397
Rotonya Carr, MD (PRINCIPAL_INVESTIGATOR)
Manish Dhyani, MD (PRINCIPAL_INVESTIGATOR)

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By research site
University of Washington· Seattle, WA

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