Accurate Point of Care Liver Disease Diagnostics

NCT05986916 | Active Not Recruiting FDA Device

• 3 other identifiers: 8062221R43DK135225-011R43EB034626-01A1
• Study Type: observational
• Target: 50
• 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. 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

Conditions

NAFLD; Nonalcoholic Fatty Liver

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Repeatability and reproducibility coefficients of LiverScope® T1 measurements

  Up to 3 months

• Correlation coefficient between LiverScope® T1 and T2 measurements and MRS T1 and T2 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: FibroScan® exam (optional); Other: Blood draw; Other: Body measurements; Other: Questionnaires

Interventions

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

MR exam DIAGNOSTIC_TEST

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

Single arm

FibroScan® exam (optional) DIAGNOSTIC_TEST

Participants may undergo a FibroScan® exam (optional) to evaluate liver fat and liver stiffness.

Single arm

Blood draw OTHER

Participants will undergo a blood draw (approximately 10 mL) for measurement of CBC, platelets, and complete metabolic panel with transaminases.

Single arm

Body measurements OTHER

Participants will have their height, weight, waist circumference, and hip circumference measured.

Single arm

Questionnaires OTHER

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

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 clinically known or suspected liver disease.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

University of California San Diego

La Jolla, California, 92037, United States

Location

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

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: August 1, 2023
• First Posted: August 14, 2023
• Study Start: August 3, 2023
• Primary Completion: November 1, 2025
• Study Completion: November 1, 2025
• Last Updated: October 23, 2025

Record last verified: 2025-10

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)