Recruiting

Observational Study

Sponsor:

ContextVision AB

Code:

NCT07270601

Conditions

MASLD - Metabolic Dysfunction-Associated Steatotic Liver Disease

NAFLD - Non-Alcoholic Fatty Liver Disease

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Interventions

Verasonics NXT Data Acquisition System

Philips EPIQ Elite

EchoSense FibroScan

Philips 3T Ingenia Elition

Study Details

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

Study ID

NCT07270601

Start date

Nov 17, 2025

Status verified date

Nov, 2025

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Oct 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

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 Design

Enrollment

110 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

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.

Interventions

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

Philips EPIQ Elite

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

EchoSense FibroScan

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

Philips 3T Ingenia Elition

A 3-tesla magnetic resonance imaging (MRI) system

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Laura Sissons-Ross Research Manager

206-616-0397lsissons@uw.edu

Locations

University of Washington

Recruiting

Seattle, Washington, United States, 98195

Contacts

Research Fellow

206-616-0397madhvi@uw.edu

Principal Investigator:

Rotonya Carr, MD

More Information

Sponsor

ContextVision AB

Last update posted

Dec 8, 2025

Last verified

Nov, 2025

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by ContextVision AB on 2025-12-08.