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

NCT07373769 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 145

Last updated 2026-01-28

No results posted yet for this study

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

Interventions

DEVICE

Ultrasound and magentic resonance imaging

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.

Sponsors & Collaborators

  • Philips Health Care

    collaborator INDUSTRY

  • Sonic Incytes

    collaborator INDUSTRY

  • University of British Columbia

    lead OTHER

Eligibility

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

Timeline & Regulatory

Start
2026-01-01
Primary Completion
2031-12-31
Completion
2032-07-01
FDA Device
Yes

Countries

  • Canada

Study Locations

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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 NCT07373769 on ClinicalTrials.gov