Accurate Point of Care Liver Disease Diagnostics (Phase 2)

NCT07518784 | Recruiting

• 2 other identifiers: 8141002R44DK135225-02
• Study Type: observational
• Target: 26
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• Agreement of LiverScope® measurements compared to conventional MR

  Assessment of agreement between LiverScope® measurements and conventional MR measurements in the liver.

  Up to 3 months

• Repeatability and reproducibility of LiverScope® measurements

  Estimation of repeatability and reproducibility coefficients of liver measurements made by LiverScope®.

  Up to 3 months

Other Outcomes (1)

• Liver T1, T2, and stiffness measurements

  Up to 3 months.

Study Arms (1)

Single arm

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

Diagnostic Test: LiverScope® exam; Diagnostic Test: MR exam; Diagnostic Test: Blood draw; Other: Body measurements; Other: Questionnaire

Interventions

MR exam DIAGNOSTIC_TEST

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

Also known as: MRI, MRI exam

Single arm

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).

Single arm

Body measurements OTHER

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

Single arm

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).

Single arm

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).

Single arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adults with known or clinically suspected MASLD.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, San Diego: lead
• Livivos, Inc.: collaborator
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

University of California San Diego

La Jolla, California, 92037, United States

RECRUITING

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease

Interventions

Blood Specimen Collection; Body Weights and Measures; Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques; Body Constitution; Physical Examination; Anthropometry; Physiological Phenomena; Data Collection; Epidemiologic Methods; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Claude B Sirlin, MD

  University of California, San Diego

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yesenia Covarrubias

CONTACT

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

Gage Tanzman

CONTACT

g1tanzman@health.ucsd.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Radiology

Study Record Dates

• First Submitted: April 1, 2026
• First Posted: April 9, 2026
• Study Start: April 8, 2026
• Primary Completion: June 30, 2026
• Study Completion: June 30, 2026
• Last Updated: April 9, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: One year after completion
• Access Criteria: Public

Locations

US (1)