Accurate Point of Care Liver Disease Diagnostics (Phase 2)

Part of paid clinical trials in La Jolla, California.

Sponsor
University of California, San Diego
Study ID
NCT07518784
Status
Recruiting
Apply to this trial

Conditions

  • MASLD
  • MASLD (Metabolic Dysfunction-Associated Steatotic Liver Disease)
  • NAFLD
  • NAFLD (Nonalcoholic Fatty Liver Disease)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • LiverScope® exam — DIAGNOSTIC_TEST
    Participants will undergo a LiverScope® examination to measure liver proton density fat fraction (PDFF, primary) and T1 and T2 values (exploratory).
  • MR exam — DIAGNOSTIC_TEST
    Participants will undergo an advanced MR examination to measure liver PDFF, T1, T2, and liver stiffness values.
  • Blood draw — DIAGNOSTIC_TEST
    A blood sample of approximately 10 mL will be collected for routine laboratory tests including complete blood count (CBC) and comprehensive metabolic panel (CMP).
  • Body measurements — OTHER
    Height, weight, waist circumference, and hip circumference will be measured.
  • Questionnaire — OTHER
    A questionnaire will be administered to collect demographic information (including age, sex, race, and ethnicity), and medical and social history (including alcohol use, tobacco use, history of diabetes, history of liver disease, and current medications).

Study Details

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

Key Dates

Start date
Apr 8, 2026
Status verified
Apr 2026
Primary completion
Jun 30, 2026
Completion
Jun 30, 2026

Study Design

Enrollment
26 participants (estimated)

Arms

  • Arm: Single arm
    This is a single arm study in which all participants undergo the same research procedures.

Primary Outcome Measure

Agreement of LiverScope® measurements compared to conventional MR [ Time Frame: Up to 3 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of California San DiegoLa JollaCalifornia92037
Yesenia Covarrubias
[email protected]
858-246-2193
Gage Tanzman
[email protected]
Claude B Sirlin, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in La Jolla, CA

By research site
University of California San Diego· La Jolla, CA

Related Studies