Ultrasound Biomarker for Fatty Liver Disease

(LYNX Trial)

Overseen By Laura Sissons-Ross Research Manager

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: ContextVision AB

Disqualifiers: Pregnancy, BMI > 35, Alcohol use, Hepatitis, Cirrhosis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

110 Participants Needed

What You Need to Know Before You Apply

What is the purpose of 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.

Are You a Good Fit for This Trial?

This trial is for individuals with conditions related to excess liver fat, such as Nonalcoholic Steatohepatitis and various forms of Fatty Liver Disease. The study aims to include those who may benefit from a non-invasive diagnostic tool due to the risks or limitations associated with current methods like MRI or biopsy.

Inclusion Criteria

I agree to participate in the study.

I am between 18 and 75 years old and healthy with no signs of liver disease.

I am 18-75 years old, suspected or diagnosed with MASLD, or at high risk for cardiometabolic issues.

Exclusion Criteria

Pregnancy or nursing

Contraindications to MRI including 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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Data Collection

Collection of raw radiofrequency data and other clinical and radiological datasets from healthy volunteers and subjects with MASLD

1 year

Follow-up

Participants are monitored for safety and effectiveness after data collection

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Development of a Quantifiable Ultrasound Biomarker

Trial Overview The study is testing new ultrasound technologies (Philips 3T Ingenia Elition, Verasonics NXT Data Acquisition System, Philips EPIQ Elite, EchoSense FibroScan) to measure liver fat percentage non-invasively. This could lead to an easier way for doctors to monitor liver health in patients at risk of MASLD.

How Is the Trial Designed?

Group I: Cohort Experimental Treatment 4 Interventions

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.

Who Is Running the Clinical Trial?

ContextVision AB

Lead Sponsor

University of Washington

Collaborator

Trials

1,858

Recruited

2,023,000+