Accurate Point of Care Liver Disease Diagnostics

Study Overview
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Brief Summary
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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

Official Title
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Accurate Point of Care Liver Disease Diagnostics

Conditions
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NAFLD, Nonalcoholic Fatty Liver

Intervention / Treatment
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* Diagnostic Test: Liverscope® exam
* Diagnostic Test: MR exam
* Diagnostic Test: FibroScan® exam (optional)
* Other: Blood draw
* Other: Body measurements
* Other: Questionnaires


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Single arm<br>This is a single arm study in which all participants undergo the same research procedures. | Diagnostic Test: Liverscope® exam<br>* Participants will undergo a LiverScope® examination to measure liver proton density fat fraction (PDFF, primary) and T1 and T2 values (exploratory).<br>Diagnostic Test: MR exam<br>* Participants will undergo an advanced MR examination to measure liver PDFF, T1, T2, and liver stiffness values.<br>Diagnostic Test: FibroScan® exam (optional)<br>* Participants may undergo a FibroScan® exam (optional) to evaluate liver fat and liver stiffness.<br>Other: Blood draw<br>* Participants will undergo a blood draw (approximately 10 mL) for measurement of CBC, platelets, and complete metabolic panel with transaminases.<br>Other: Body measurements<br>* Participants will have their height, weight, waist circumference, and hip circumference measured.<br>Other: Questionnaires<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Repeatability and reproducibility coefficients of LiverScope® PDFF measurements | Estimation of repeatability and reproducibility coefficients of liver PDFF values measured by LiverScope®. | Up to 3 months | 
| Agreement of LiverScope® PDFF measurements with MRI PDFF measurements | Assessment of the agreement between LiverScope® PDFF measurements and MRI PDFF measurements. | Up to 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Repeatability and reproducibility coefficients of LiverScope® T1 measurements | Estimation of repeatability and reproducibility coefficients of liver T1 values estimated by LiverScope®. | Up to 3 months | 
| Correlation coefficient between LiverScope® T1 and T2 measurements and MRS T1 and T2 measurements | Estimation of the correlation coefficient between LiverScope® T1 and T2 measurements and MRS T1 and T2 measurements. | Up to 3 months |