Accurate Point of Care Liver Disease Diagnostics

University of California San Diego

Status: Active, not recruiting

Conditions: Nonalcoholic Fatty Liver; NAFLD

Treatments: Diagnostic Test: MR exam; Other: Body measurements; Diagnostic Test: Liverscope® exam; Other: Questionnaires; Other: Blood draw; Diagnostic Test: FibroScan® exam (optional)

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT05986916

806222

1R43EB034626-01A1 (U.S. NIH Grant/Contract)

1R43DK135225-01 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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

Enrollment: 50 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

50 participants in 1 patient group

Single arm

Description:

This is a single arm study in which all participants undergo the same research procedures.

Treatment:

Other: Blood draw

Diagnostic Test: FibroScan® exam (optional)

Other: Questionnaires

Other: Body measurements

Diagnostic Test: Liverscope® exam

Diagnostic Test: MR exam