Accurate Point of Care Liver Disease Diagnostics
- Conditions
- Nonalcoholic Fatty LiverNAFLD
- Interventions
- Diagnostic Test: Liverscope® examDiagnostic Test: MR examDiagnostic Test: FibroScan® exam (optional)Other: Blood drawOther: Body measurementsOther: Questionnaires
- Registration Number
- NCT05986916
- Lead Sponsor
- University of California, San Diego
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 50
- 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
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Single arm Body measurements This is a single arm study in which all participants undergo the same research procedures. Single arm Liverscope® exam This is a single arm study in which all participants undergo the same research procedures. Single arm MR exam This is a single arm study in which all participants undergo the same research procedures. Single arm Blood draw This is a single arm study in which all participants undergo the same research procedures. Single arm FibroScan® exam (optional) This is a single arm study in which all participants undergo the same research procedures. Single arm Questionnaires This is a single arm study in which all participants undergo the same research procedures.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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.
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®.
Trial Locations
- Locations (1)
University of California San Diego
🇺🇸La Jolla, California, United States