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.
The objective is to develop a novel multiparametric ultrasound-based technique to quantify the amount of steatosis in the liver by using the current MRI-based gold-standard - MRI proton density fat fraction (MRI-PDFF) as a clinical reference. This clinical development study will only collect the required dataset from healthy volunteers and subjects with different degrees of steatosis in the liver, particularly patients with MASLD, formerly non-alcoholic fatty liver disease (NAFLD). It will capture the raw radiofrequency data required for the development of this new radiologic biomarker on a research ultrasound imaging device. In addition, various other clinical and radiological datasets will be captured to support the ground truthing, development and training of the novel ultrasound-based multiparametric biomarker.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
110
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
A premium ultrasound system with software package to support imaging research studies.
A non-invasive ultrasound solution that accurately measures liver stiffness and liver steatosis.
A 3-tesla magnetic resonance imaging (MRI) system
University of Washington
Seattle, Washington, United States
RECRUITINGMultiparametric 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.
Time frame: 1 year
Individual Ultrasound parameter vs. MRI-PDFF
Evaluation of each ultrasound parameter (backscatter, attenuation and speed of sound) fat percentage values separately against MRI-PDFF.
Time frame: 1 year
Ultrasound Shear Wave vs MR Elastography
Evaluation of ultrasound shear wave elastography-derived tissue stiffness values in kilopascals compared to MR elastography.
Time frame: 1 year
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