Ultrasound Liver Imaging for Classification of Metabolic Dysfunction-associated Steatotic Liver Disease

NCT07373769 | Not Yet Recruiting FDA Device

• 1 other identifier: H25-01810
• Study Type: observational
• Target: 145
• Locations: 1 country
• Sites: 1

Brief Summary

Tissue elasticity and viscosity correlate with pathology. These tissue properties are typically evaluated subjectively using palpation. The purpose of "elastography" is to provide an objective elasticity image that is equivalent to the remote palpation of tissue. The investigators have developed elastography imaging systems based on ultrasound and magnetic resonance imaging and have applied them previously to prostate imaging, breast imaging in patients and liver imaging in healthy volunteers. A first objective of this study is to compare the investigators' ultrasound shear wave absolute vibro-elastography (S-WAVE) technology with the existing clinical standard, FibroScan, and magnetic resonance elastography to quantify liver stiffness in healthy volunteers and in patients suspected of fatty liver disease. A second objective of this study is to compare ultrasound-based liver tissue fat measurement with MRI-based measurements. A third objective of this study is to determine whether ultrasound can be used to assess liver inflammation.

Conditions

Metabolic Dysfunction-Associated Steatotic Liver Disease

Keywords

steatosis; fibrosis; Metabolic dysfunction-associated steatotic liver disease; inflammation; liver

Outcome Measures

Primary Outcomes (1)

• Comparison of liver elasticity measurement between magnetic resonance imaging and ultrasound.

  Measurements of liver elasticity measurements acquired with magnetic resonance elastography will be compared to those acquired with ultrasound. Measurements of liver fat content with magnetic resonance imaging and ultrasound will be compared. The measurements will be taken within at most two months of each other. There is no outcome related to this imaging study, it is rather a comparison of liver fibrosis and steatosis image-based measurements, with the goal of offering an alternative to quantitative MRI imaging using quantitative ultrasound. Ability of ultrasound to predict biopsy results will be assessed.

  Through study completion, an average of 5 years.

Study Arms (2)

healthy volunteers

who have no known history of liver disease

Device: Ultrasound and magentic resonance imaging

patients with chronic liver disease

with fibrosis stages F0, F1, F2, F3 or F4.

Device: Ultrasound and magentic resonance imaging

Interventions

Ultrasound and magentic resonance imaging DEVICE

For each healthy volunteer and patient, there will be two sessions of imaging. Magnetic resonance imaging, including proton density fat fraction (PDFF) and elastography (MRE) will be acquired. Multi-paramteric, volumetric ultrasound will also be acquired, including shear wave absolute elastography and attenuation, as well as raw radio-frequecy (echo) data. Two systems, a Philips Epiq and a Sonic Incytes Velacur will be used to acquire ultrasound images, including elasticity and attenuation. In addition, Fibroscan measurements (Liver Stiffness measurement and Controlled Attenuation Parameter) will be acquired.

healthy volunteers; patients with chronic liver disease

Eligibility Criteria

• Age: 19 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Healthy volunteers from the University of British Columbia and gastroenterology patients with chronic liver disease from the Vancouver General Hospital or from the St. Paul's hospital, both from Vancouver, British Columbia.

You may qualify if:

• Participants between the ages of 19 and 75.
• healthy volunteers and have no known history of liver disease
• patients with chronic liver disease, with fibrosis stages F0, F1, F2, F3 or F4.

You may not qualify if:

• Does not speak and/or read English
• CANNOT undergo an MRI exam for one of the following reasons:
• Retained wires from an electronic implant that has been removed (i.e. pacemaker wires not attached to a pacemaker)
• Cardiac pacemaker or defibrillator
• Metal in eye or orbit
• Ferromagnetic aneurysm clip
• Pregnancy
• Makeup tattoos that are not designed to fade over time
• Stainless steel intrauterine device (IUD)
• Depending on the individual situation, patients MAY NOT be able to participate the MRI exam if they have/had any of the following:
• Artificial heart valve
• Ear or eye implant
• Brain aneurysm clip
• Implanted electronic device (i.e. drug infusion pump, electrical stimulator)
• Coil, catheter, or filter in any blood vessel

Sponsors & Collaborators

• University of British Columbia: lead
• Philips Health Care: collaborator
• Sonic Incytes: collaborator

Study Sites (1)

University of British Columbia

Vancouver, British Columbia, V6T1Z4, Canada

Location

MeSH Terms

Conditions

Fatty Liver; Fibrosis; Inflammation

Interventions

Ultrasonography

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Central Study Contacts

Septimiu Salcudean, PhD

CONTACT

1(604)822-3243; tims@ece.ubc.ca

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 23, 2025
• First Posted: January 28, 2026
• Study Start: January 1, 2026
• Primary Completion (Estimated): December 31, 2031
• Study Completion (Estimated): July 1, 2032
• Last Updated: January 28, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)