Recruiting
Not applicable
Development of a Quantifiable Ultrasound Biomarker for Hepatic Steatosis
Condition(s) studied
MASLD - Metabolic Dysfunction-Associated Steatotic Liver DiseaseNAFLD - Non-Alcoholic Fatty Liver Disease
Investigational drug(s) / intervention(s)
Verasonics NXT Data Acquisition SystemPhilips EPIQ EliteEchoSense FibroScanPhilips 3T Ingenia Elition
Verasonics NXT Data Acquisition System: 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
Philips EPIQ Elite: A premium ultrasound system with software package to support imaging research studies.
EchoSense FibroScan: A non-invasive ultrasound solution that accurately measures liver stiffness and liver steatosis.
Philips 3T Ingenia Elition: A 3-tesla magnetic resonance imaging (MRI) system
Study summary
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.
Eligibility
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 syndrome, diabetes mellitus, obesity, insulin resistance, dyslipidemia, etc.)
Exclusion Criteria:
* 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
* History of excessive alcohol consumption according to the updated MASLD criteria (\>2 drinks/day OR \>210 grams/week for males AND \>1 drink/day OR \>140 grams/week for females) or drug use over the past 2 years.
* Known acute or chronic hepatitis; or other etiology of liver disease.
* Presence of known congenital hepatic anomaly.
* Known cirrhosis
* Known active cancer
Primary outcome measure(s)
- Multiparametric Ultrasound Biomarker vs. MR-PDFF — 1 year
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.
Trial sites (1)
| Facility | City | Region | Status |
|---|
| University of Washington |
Seattle |
Washington |
Recruiting |