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. The investigators are testing a new technology to evaluate the liver (LiverScope®), and they will compare it to other methods to evaluate the liver, including advanced conventional liver MR and liver FibroScan® ultrasound exams. MR exams and FibroScan® ultrasound exams are common exams used to monitor 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 study the investigators will learn how LiverScope® measurements of the liver compare to MR.

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: Active, not recruiting
• Conditions: NAFLD; Nonalcoholic Fatty Liver
• Intervention / Treatment: Diagnostic test: Liverscope® exam; Diagnostic test: MR exam; Diagnostic test: FibroScan® exam (optional); Other: Blood draw; Other: Body measurements; Other: Questionnaires

• Study Type: Observational
• Enrollment (Estimated): 50

Contacts and Locations

Study Locations

• United States
  • California
    • La Jolla, California, United States, 92037
      • University of California San Diego

Participation Criteria

Eligibility Criteria

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

• Sampling Method: Non-Probability Sample

Study Population

Adults with clinically known or suspected liver disease.

Description

Inclusion Criteria:

• Age:18 years or older
• Known or clinically suspected NAFLD
• Weight less than 350 lbs (safety limit of MR scanner table)
• Able to lie on LiverScope® diagnostic table for about 15 min
• Able to hold breath repeatedly for about 20 s during MR and LiverScope® exams
• Willing and able to undergo all study procedures

Exclusion Criteria:

• VA patient only; not a UCSD patient
• UCSD or Livivos study personnel
• MR contraindication(s)
• Potential participant states that she knows that she is pregnant, thinks she may be pregnant or states she is trying to become pregnant*
• Known chronic liver disease other than NAFLD

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: 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: FibroScan® exam (optional); Participants may undergo a FibroScan® exam (optional) to evaluate liver fat and liver stiffness.; Other: Blood draw; Participants will undergo a blood draw (approximately 10 mL) for measurement of CBC, platelets, and complete metabolic panel with transaminases.; Other: Body measurements; Participants will have their height, weight, waist circumference, and hip circumference measured.; Other: Questionnaires; Participants will be asked to fill out questionnaires to collect information about their alcohol consumption, history of cigarette smoking, presence of diabetes, and history of liver disease and medications

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Repeatability and reproducibility coefficients of LiverScope® PDFF measurements	Estimation of repeatability and reproducibility coefficients of liver PDFF values measured by LiverScope®.	Up to 3 months
Agreement of LiverScope® PDFF measurements with MRI PDFF measurements	Assessment of the agreement between LiverScope® PDFF measurements and MRI PDFF measurements.	Up to 3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Repeatability and reproducibility coefficients of LiverScope® T1 measurements	Estimation of repeatability and reproducibility coefficients of liver T1 values estimated by LiverScope®.	Up to 3 months
Correlation coefficient between LiverScope® T1 and T2 measurements and MRS T1 and T2 measurements	Estimation of the correlation coefficient between LiverScope® T1 and T2 measurements and MRS T1 and T2 measurements.	Up to 3 months

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): August 3, 2023
• Primary Completion (Estimated): November 1, 2025
• Study Completion (Estimated): November 1, 2025

Study Registration Dates

• First Submitted: August 1, 2023
• First Submitted That Met QC Criteria: August 8, 2023
• First Posted (Actual): August 14, 2023

Study Record Updates

• Last Update Posted (Estimated): October 23, 2025
• Last Update Submitted That Met QC Criteria: October 21, 2025
• Last Verified: October 1, 2025

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: 806222; 1R43DK135225-01 (U.S. NIH Grant/Contract); 1R43EB034626-01A1 (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 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: Yes
• product manufactured in and exported from the U.S.: No