Accurate Point of Care Liver Disease Diagnostics

NCT05986916 — Active not recruiting, 50 participants, University of California, San Diego

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Registry	NCT05986916
Status	Active not recruiting
Study type	Observational
Enrollment	50 (Estimated)
Sponsor	University of California, San Diego (Other); collaborators: Livivos, Inc., National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), National Institute for Biomedical Imaging and Bioengineering (NIBIB)
Conditions	NAFLD, Nonalcoholic Fatty Liver
Interventions	Liverscope® exam, MR exam, FibroScan® exam (optional), Blood draw, Body measurements, Questionnaires (Diagnostic test, other)
Dates	start 2023-08-03, primary completion 2025-11-01 (estimated), completion 2025-11-01 (estimated), first posted 2023-08-14, last updated 2025-10-23
Locations	1 site in United States

-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

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+Arms and interventions

Arm	Type	Interventions	Description
Single arm		Diagnostic Test: Liverscope® exam; Diagnostic Test: MR exam; Diagnostic Test: FibroScan® exam (optional); Other: Blood draw; Other: Body measurements; Other: Questionnaires	This is a single arm study in which all participants undergo the same research procedures.

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).
MR exam (Diagnostic test): Participants will undergo an advanced MR examination to measure liver PDFF, T1, T2, and liver stiffness values.
FibroScan® exam (optional) (Diagnostic test): Participants may undergo a FibroScan® exam (optional) to evaluate liver fat and liver stiffness.
Blood draw (Other): Participants will undergo a blood draw (approximately 10 mL) for measurement of CBC, platelets, and complete metabolic panel with transaminases.
Body measurements (Other): Participants will have their height, weight, waist circumference, and hip circumference measured.
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

+Outcome measures

Primary outcomes

Repeatability and reproducibility coefficients of LiverScope® PDFF measurements [Up to 3 months]: Estimation of repeatability and reproducibility coefficients of liver PDFF values measured by LiverScope®.
Agreement of LiverScope® PDFF measurements with MRI PDFF measurements [Up to 3 months]: Assessment of the agreement between LiverScope® PDFF measurements and MRI PDFF measurements.

Secondary outcomes

Repeatability and reproducibility coefficients of LiverScope® T1 measurements [Up to 3 months]: Estimation of repeatability and reproducibility coefficients of liver T1 values estimated by LiverScope®.
Correlation coefficient between LiverScope® T1 and T2 measurements and MRS T1 and T2 measurements [Up to 3 months]: Estimation of the correlation coefficient between LiverScope® T1 and T2 measurements and MRS T1 and T2 measurements.

+Eligibility

Sex: All, ages: 18 Years to any

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

+Locations (1)

Facility	City	Country	Status
University of California San Diego	La Jolla, California	United States

+Investigators

Claude B Sirlin, MD, Principal investigator, University of California, San Diego

+Funding

NIH grants: R43DK135225, R43EB034626