About this trial

This research study is being conducted to find out more about techniques to non-invasively evaluate liver disease. This is the second phase of a project in which we are testing a new technology to evaluate the liver (LiverScope®). We will compare LiverScope® to other methods to evaluate the liver, including advanced conventional liver MR exams. MR exams are common exams used to monitor MASLD (also known as NAFLD). Conventional MR scanners use magnetic fields and radio waves to make pictures of the liver. LiverScope® is a small, portable MR-based device that uses similar, but simplified technology, and can be used on top of an exam table in an outpatient setting. LiverScope® currently is not approved for clinical use.

In this second phase of the study, we took what we learned in the first phase to optimize the LiverScope® device and are now testing to see how LiverScope® measurements compare to MR after these optimizations.

Study participants will be asked to complete a one-time visit which includes:

* LiverScope exam * MR exam * FibroScan exam (optional) * Blood draw * Completion of study questionnaires

Eligibility criteria

Qualifiers

Age ≥ 18 years

Known or clinically suspected MASLD

BMI greater than 27 kg/m² and less than 45 kg/m² at the time of referral

Ability to lie on LiverScope® device table for about 60 minutes

Disqualifiers

UCSD study personnel or Livivos study personne

Contraindications to MR

Potential participant states that she knows that she is pregnant, thinks she may be pregnant, or states that she is trying to become pregnant.

Known chronic liver disease other than MASLD

Trial design

Treatments tested in this trial

  • LiverScope® exam
  • MR exam
  • Blood draw
  • Body measurements
  • Questionnaire

Treatment groups

26 Participants
are divided into 1 treatment group

Locations

1
University of California San Diego92037, La JollaCalifornia, United States

Sponsors and collaborators

University of California, San Diego

Lead sponsor

Livivos, Inc.

Collaborator

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator