Recruiting

LiverScope®

Sponsor:

UCLA

Code:

NCT07518784

Conditions

MASLD

MASLD (Metabolic Dysfunction-Associated Steatotic Liver Disease)

NAFLD

NAFLD (Nonalcoholic Fatty Liver Disease)

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

LiverScope® exam

MR exam

Blood draw

Body measurements

Questionnaire

Study Details

Brief 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

Conditions

MASLD

MASLD (Metabolic Dysfunction-Associated Steatotic Liver Disease)

NAFLD

NAFLD (Nonalcoholic Fatty Liver Disease)

Study ID

NCT07518784

Start date

Apr 8, 2026

Status verified date

Apr, 2026

Completion date

Jun 30, 2026

Anticipated

Primary completion date

Jun 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

26 participants

Anticipated

Interventions and Outcome Measures

Arms

Single arm

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

Interventions

LiverScope® exam

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

MR exam

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

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).

Body measurements

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

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).

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Yesenia Covarrubias

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

Gage Tanzman

g1tanzman@health.ucsd.edu

Locations

University of California San Diego

Recruiting

La Jolla, California, United States, 92037

Contacts

Yesenia Covarrubias

858-246-2193ycovarrubias@health.ucsd.edu

Gage Tanzman

g1tanzman@health.ucsd.edu

Principal Investigator:

Claude B Sirlin, MD

More Information

Sponsor

University of California, San Diego

Last update posted

Apr 9, 2026

Last verified

Apr, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of California, San Diego on 2026-04-09.