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.
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)
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
Single group
Verasonics NXT Data Acquisition System
DeviceA 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
DeviceA premium ultrasound system with software package to support imaging research studies.
EchoSense FibroScan
DeviceA non-invasive ultrasound solution that accurately measures liver stiffness and liver steatosis.
Philips 3T Ingenia Elition
DeviceA 3-tesla magnetic resonance imaging (MRI) system
Multiparametric Ultrasound Biomarker vs. MR-PDFF
Clinical qualification of the multiparametric ultrasound-derived fat fraction, defined as its agreement with the established clinical reference, MRI proton density fat fraction (MRI-PDFF) expressed as absolute percentage, in bench testing analysis.
Individual Ultrasound parameter vs. MRI-PDFF
Evaluation of each ultrasound parameter (backscatter, attenuation and speed of sound) fat percentage values separately against MRI-PDFF.
Ultrasound Shear Wave vs MR Elastography
Evaluation of ultrasound shear wave elastography-derived tissue stiffness values in kilopascals compared to MR elastography.
Click on the lead sponsor to view all of their trials.
ContextVision AB
Lead sponsor
University of Washington
Collaborator
