Development of a Quantifiable Ultrasound Biomarker for Hepatic Steatosis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Verasonics NXT Data Acquisition System, Philips EPIQ Elite, EchoSense FibroScan, Philips 3T Ingenia Elition.
- Who it may be relevant to
- Registry conditions: MASLD - Metabolic Dysfunction-Associated Steatotic Liver Disease, NAFLD - Non-Alcoholic Fatty Liver Disease. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Development and Diagnostic Evaluation of a Novel Quantifiable Ultrasound Based Multi-parametric Biomarker for Hepatic Steatosis in Patients With Suspected MASLD ( LYNX )
Overview
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
- Device 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 - Device Philips EPIQ Elite
A premium ultrasound system with software package to support imaging research studies. - Device EchoSense FibroScan
A non-invasive ultrasound solution that accurately measures liver stiffness and liver steatosis. - Device Philips 3T Ingenia Elition
A 3-tesla magnetic resonance imaging (MRI) system
Primary outcome measures
- Multiparametric Ultrasound Biomarker vs. MR-PDFF [Time frame: 1 year]
Secondary outcome measures (2)
- Individual Ultrasound parameter vs. MRI-PDFF [Time frame: 1 year]
- Ultrasound Shear Wave vs MR Elastography [Time frame: 1 year]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
United States · 1 center
- University of Washington — Seattle
Identifiers
NCT: NCT07270601 · COV-POCUS-001