RecruitingNCT07518784

Accurate Point of Care Liver Disease Diagnostics (Phase 2)

Accurate Point of Care Liver Disease Diagnostics

Sponsor

University of California, San Diego

Enrollment

26 participants

Start Date

Apr 8, 2026

Study Type

OBSERVATIONAL

Conditions

MASLD

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

Eligibility

Min Age: 18 Years

Inclusion Criteria6

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 Criteria4

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

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Interventions

DIAGNOSTIC_TESTLiverScope® exam

Participants will undergo a LiverScope® examination to measure liver proton density fat fraction (PDFF, primary) and T1 and T2 values (exploratory).

DIAGNOSTIC_TESTMR exam

Participants will undergo an advanced MR examination to measure liver PDFF, T1, T2, and liver stiffness values.

DIAGNOSTIC_TESTBlood draw

A blood sample of approximately 10 mL will be collected for routine laboratory tests including complete blood count (CBC) and comprehensive metabolic panel (CMP).

OTHERBody measurements

Height, weight, waist circumference, and hip circumference will be measured.

OTHERQuestionnaire

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).