Accurate Point of Care Liver Disease Diagnostics (Phase 2)

Accurate Point of Care Liver Disease Diagnostics

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

Study Overview

• Status: Recruiting
• Conditions: NAFLD; NAFLD (Nonalcoholic Fatty Liver Disease); MASLD; MASLD (Metabolic Dysfunction-Associated Steatotic Liver Disease)
• Intervention / Treatment: Diagnostic test: MR exam; Diagnostic test: LiverScope® exam; Diagnostic test: Blood draw; Other: Body measurements; Other: Questionnaire

• Study Type: Observational
• Enrollment (Estimated): 26

Contacts and Locations

• Study Contact: Name: Yesenia Covarrubias; Phone Number: 858-246-2198; Email: ycovarrubias@health.ucsd.edu
• Study Contact Backup: Name: Gage Tanzman; Email: g1tanzman@health.ucsd.edu

Study Locations

• United States
  • California
    • La Jolla, California, United States, 92037
      • Recruiting
      • University of California San Diego
      • Principal Investigator: Claude B Sirlin, MD
      • Contact: Gage Tanzman; Email: g1tanzman@health.ucsd.edu
      • Contact: Yesenia Covarrubias; Phone Number: 858-246-2193; Email: ycovarrubias@health.ucsd.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Adults with known or clinically suspected MASLD.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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

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: 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: 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Liver T1, T2, and stiffness measurements	Using MR spectroscopy, T1 and T2 of liver tissue will be measured. Liver stiffness will be measured by MR Elastography. These data will enable confounder testing.	Up to 3 months.

Collaborators and Investigators

• Sponsor: University of California, San Diego
• Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK); Livivos, Inc.
• Investigators: Principal Investigator: Claude B Sirlin, MD, University of California, San Diego

Study record dates

Study Major Dates

• Study Start (Estimated): April 8, 2026
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026

Study Registration Dates

• First Submitted: April 1, 2026
• First Submitted That Met QC Criteria: April 1, 2026
• First Posted (Actual): April 9, 2026

Study Record Updates

• Last Update Posted (Actual): April 9, 2026
• Last Update Submitted That Met QC Criteria: April 1, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease; Health Care Quality, Access, and Evaluation; Investigative Techniques; Epidemiologic Methods; Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Data Collection; Health Care Evaluation Mechanisms; Quality of Health Care; Public Health; Environment and Public Health; Physiological Phenomena; Physical Examination; Body Constitution; Anthropometry; Surveys and Questionnaires; Blood Specimen Collection; Body Weights and Measures
• Other Study ID Numbers: 814100; 2R44DK135225-02 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: This is an NIH SBIR study. De-identified coded data will be shared as per grant application.
• IPD Sharing Time Frame: One year after completion
• IPD Sharing Access Criteria: Public
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No