Development of a Quantifiable Ultrasound Biomarker for Hepatic Steatosis

NCT ID: NCT07270601

Last Updated: 2025-12-08

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 110 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-11-17
• Study Completion Date: 2026-12-31

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.

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Verasonics NXT Data Acquisition System

Intervention Type: 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

Intervention Type: DEVICE

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

EchoSense FibroScan

Intervention Type: DEVICE

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

Philips 3T Ingenia Elition

Intervention Type: DEVICE

A 3-tesla magnetic resonance imaging (MRI) system

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

Intervention Type: DEVICE

Philips EPIQ Elite

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

Intervention Type: DEVICE

EchoSense FibroScan

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

Intervention Type: DEVICE

Philips 3T Ingenia Elition

A 3-tesla magnetic resonance imaging (MRI) system

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

ContextVision AB

INDUSTRY

Sponsor Role: lead

University of Washington

OTHER

Sponsor Role: collaborator

Responsible Party

Responsibility Role: SPONSOR

Locations

University of Washington

Seattle, Washington, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Laura Sissons-Ross Research Manager

Role: CONTACT

lsissons@uw.edu

206-616-0397

Facility Contacts

Research Fellow

Role: primary

madhvi@uw.edu

206-616-0397

Other Identifiers

COV-POCUS-001

Identifier Type: -

Identifier Source: org_study_id