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Development of a Quantifiable Ultrasound Biomarker for Hepatic Steatosis

NCT07270601 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 110

Last updated 2025-12-08

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-11-17
Primary Completion
2026-10-31
Completion
2026-12-31
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07270601 on ClinicalTrials.gov