MASLD - Metabolic Dysfunction-Associated Steatotic Liver Disease, NAFLD - Non-Alcoholic Fatty Liver Disease
Conditions
Keywords
MASLD, NAFLD, Ultrasound, Steatosis, Fibrosis, MRI-PDFF
Brief 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.
Detailed description
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.
Interventions
DEVICEVerasonics 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
DEVICEPhilips EPIQ Elite
A premium ultrasound system with software package to support imaging research studies.
DEVICEEchoSense FibroScan
A non-invasive ultrasound solution that accurately measures liver stiffness and liver steatosis.
DEVICEPhilips 3T Ingenia Elition
A 3-tesla magnetic resonance imaging (MRI) system
Sponsors
University of Washington
ContextVision AB
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Individual Ultrasound parameter vs. MRI-PDFF | 1 year | Evaluation of each ultrasound parameter (backscatter, attenuation and speed of sound) fat percentage values separately against MRI-PDFF. |
| Ultrasound Shear Wave vs MR Elastography | 1 year | Evaluation of ultrasound shear wave elastography-derived tissue stiffness values in kilopascals compared to MR elastography. |
Countries
United States
Contacts
Primary ContactLaura Sissons-Ross Research Manager
Outcome results
None listed