Ultrasound Liver Imaging for Classification of Metabolic Dysfunction-associated Steatotic Liver Disease
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age19-75
SponsorUniversity of British Columbia
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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
Trial 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.
Trial design
Design model
Cohort
Time perspective
Retrospective
Treatments tested in this trial
Ultrasound and magentic resonance imaging
DeviceFor 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.
Treatment groups
145 Participants
are divided into 2 treatment groupsGroup A: healthy volunteers1 intervention
Group B: patients with chronic liver disease1 intervention
Trial outcomes
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.
Time frame
Through study completion, an average of 5 years.Sponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: