Accurate Point of Care Liver Disease Diagnostics (Phase 2)

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)

Interventions

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.

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).

Sponsors & Collaborators

• Livivos, Inc.

  collaborator UNKNOWN

• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

  collaborator NIH

• University of California, San Diego

  lead OTHER

Principal Investigators

• Claude B Sirlin, MD · University of California, San Diego

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-04-08

Primary Completion

2026-06-30

Completion

2026-06-30

Countries

• United States

Study Locations