Accurate Point of Care Liver Disease Diagnostics
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Repeatability and reproducibility coefficients of LiverScope® PDFF measurements
Study Overview
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
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Repeatability and reproducibility coefficients of LiverScope® PDFF measurements
Time Frame: 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
Time Frame: Up to 3 months
Assessment of the agreement between LiverScope® PDFF measurements and MRI PDFF measurements.
Secondary Outcomes
- Correlation coefficient between LiverScope® T1 and T2 measurements and MRS T1 and T2 measurements(Up to 3 months)
- Repeatability and reproducibility coefficients of LiverScope® T1 measurements(Up to 3 months)
Investigators
Claude Sirlin
Professor of Radiology
University of California, San Diego