Accurate Point of Care Liver Disease Diagnostics

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

Interventions

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

Sponsors & Collaborators

• Livivos, Inc.

  collaborator UNKNOWN

• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

  collaborator NIH

• National Institute for Biomedical Imaging and Bioengineering (NIBIB)

  collaborator NIH

• University of California, San Diego

  lead OTHER

Principal Investigators

• Claude B Sirlin, MD · University of California, San Diego

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-08-03

Primary Completion

2025-11-30

Completion

2025-11-30

FDA Device

Yes

Countries

• United States

Study Locations