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Purpose

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

Conditions

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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

Study Design

Phase
Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Arm Groups

ArmDescriptionAssigned Intervention
Single arm This is a single arm study in which all participants undergo the same research procedures.
  • Diagnostic Test: LiverScope® exam
    Participants will undergo a LiverScope® examination to measure liver proton density fat fraction (PDFF, primary) and T1 and T2 values (exploratory).
  • Diagnostic Test: MR exam
    Participants will undergo an advanced MR examination to measure liver PDFF, T1, T2, and liver stiffness values.
    Other names:
    • MRI
    • MRI exam
  • Diagnostic Test: Blood 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).
  • Other: Body measurements
    Height, weight, waist circumference, and hip circumference will be measured.
  • Other: Questionnaire
    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).

Recruiting Locations

University of California San Diego
La Jolla, California 92037
Contact:
Yesenia Covarrubias
858-246-2193
ycovarrubias@health.ucsd.edu

More Details

Status
Recruiting
Sponsor
University of California, San Diego

Study Contact

Yesenia Covarrubias
858-246-2198
ycovarrubias@health.ucsd.edu

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.