NCT05986916

Accurate Point of Care Liver Disease Diagnostics

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 50 (estimated)
• Sponsor: University of California, San Diego · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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

Timeline

• Start date: 2023-08-03
• Primary completion: 2025-11-01
• Completion: 2025-11-01
• First posted: 2023-08-14
• Last updated: 2025-10-23

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study