Developing a New Ultrasound Test for Liver Fat

This study is exploring a new way to measure fat in your liver using special ultrasound devices like the Verasonics NXT Data Acquisition System, Philips EPIQ Elite, and EchoSense FibroScan. This could help doctors detect a common liver condition called metabolic dysfunction-associated steatotic liver disease (MASLD) earlier and more easily. Currently, tests like MRI or liver biopsy can be expensive or invasive. If successful, this new ultrasound method could offer a simpler, more accessible way to monitor liver health, especially for people with conditions like diabetes, obesity, high blood pressure, or high cholesterol. The study aims to enroll 110 participants aged 18 to 75, including those with suspected MASLD or certain risk factors, as well as healthy volunteers. The main goal is to see how well this new ultrasound method compares to a specialized MRI scan (MR-PDFF) in measuring liver fat after one year.

Study design
This is an interventional study planning to enroll 110 participants. It is designed to develop a new ultrasound technique to measure liver fat.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint is measured at 1 year, suggesting participants will be followed for at least this duration.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07270601

Development of a Quantifiable Ultrasound Biomarker for Hepatic Steatosis

Recruiting
NAAges 18–75InterventionalDiagnostic
ContextVision AB
~110 participants
Updated 2025-12-08 on ClinicalTrials.gov
What's tested:Verasonics NXT Data Acquisition SystemPhilips EPIQ EliteEchoSense FibroScanPhilips 3T Ingenia Elition

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Multiparametric Ultrasound Biomarker vs. MR-PDFF
Measured over 1 year
MASLD - Metabolic Dysfunction-Associated Steatotic Liver Disease
NAFLD - Non-Alcoholic Fatty Liver Disease

NCT07270601

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • University of Washington

    Seattle, Washingtonstudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Laura Sissons-Ross Research Manager
Email the study team

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Eligibility criteria

Inclusion

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)
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

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
  • Multiparametric Ultrasound Biomarker vs. MR-PDFF1 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.