Development of a Quantifiable Ultrasound Biomarker for Hepatic Steatosis

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorContextVision AB

About this trial

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 criteria

Qualifiers

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)

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Verasonics NXT Data Acquisition System
  • Philips EPIQ Elite
  • EchoSense FibroScan
  • Philips 3T Ingenia Elition

Treatment groups

110 Participants
are divided into 1 treatment group

Sponsors and collaborators

ContextVision AB

Lead sponsor

University of Washington

Collaborator