Accurate Point of Care Liver Disease Diagnostics (Phase 2)

a study on MASLD Liver Disease Nonalcoholic Fatty Liver Disease

Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UCSD
Dates
study started
study ends around
Principal Investigator
by Claude B Sirlin, MD (ucsd)
Headshot of Claude B Sirlin
Claude B Sirlin

Description

Summary

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

Official Title

Accurate Point of Care Liver Disease Diagnostics

Keywords

MASLD, MASLD (Metabolic Dysfunction-Associated Steatotic Liver Disease), NAFLD, NAFLD (Nonalcoholic Fatty Liver Disease), Non-alcoholic Fatty Liver Disease, Blood Specimen Collection, Body Weights and Measures, Surveys and Questionnaires, LiverScope® exam, MR exam, Blood draw, Body measurements

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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
  • Ability to hold breath repeatedly for about 20 seconds during MR and LiverScope® exams
  • Willing and able to undergo all study procedures

You CAN'T join if...

  • 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

Location

  • University of California San Diego accepting new patients
    La Jolla California 92037 United States

Lead Scientist at University of California Health

  • Claude B Sirlin, MD (ucsd)
    Professor, Radiology, Vc-health Sciences-schools. Authored (or co-authored) 472 research publications

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, San Diego
ID
NCT07518784
Study Type
Observational
Participants
Expecting 26 study participants
Last Updated
Contact us about this trial