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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 re…
Inclusion Criteria: Diseased subject: * 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) Healthy volunteer: * Adult patients (age 18 - 75 years) * Consent to participate in the study * No suspicion of MASLD by laboratory/imaging/clinical examinations * Absence of known pre-existing conditions (metabolic synd…
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
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