Development and Diagnostic Evaluation of a Novel Quantifiable Ultrasound Based Multi-parametric Biomarker for Hepatic Steatosis in Patients With Suspected MASLD ( LYNX )

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: t
View:

⁃ 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.)

Locations
United States
Washington
University of Washington
RECRUITING
Seattle
Contact Information
Primary
Laura Sissons-Ross Research Manager
lsissons@uw.edu
206-616-0397
Time Frame
Start Date: 2025-11-17
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 110
Treatments
Experimental: Cohort
Adult healthy volunteers as well as subjects who have a diagnosis, or suspected, of having MASLD or are deemed to meet the high-risk cardiometabolic criteria.
Sponsors
Collaborators: University of Washington
Leads: ContextVision AB

This content was sourced from clinicaltrials.gov