Accurate Point of Care Liver Disease Diagnostics (Phase 2)
Recruiting · NCT07518784 · Observational (researchers observe without assigning treatment) · Lead sponsor: University of California, San Diego
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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
Who can take part
Inclusion criteria
- Age ≥ 18 years
- Known or clinically suspected MASLD
- BMI greater than 27 kg/m\^2 and less than 45 kg/m\^2 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
Exclusion criteria
- 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
Where it is running
1 location listed across 1 US state.
- University of California San Diego - La Jolla, California, United States