NAFLD, Nonalcoholic Fatty Liver
Conditions
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
Interventions
DIAGNOSTIC_TESTLiverscope® exam
Participants will undergo a LiverScope® examination to measure liver proton density fat fraction (PDFF, primary) and T1 and T2 values (exploratory).
DIAGNOSTIC_TESTMR exam
Participants will undergo an advanced MR examination to measure liver PDFF, T1, T2, and liver stiffness values.
DIAGNOSTIC_TESTFibroScan® exam (optional)
Participants may undergo a FibroScan® exam (optional) to evaluate liver fat and liver stiffness.
OTHERBlood draw
Participants will undergo a blood draw (approximately 10 mL) for measurement of CBC, platelets, and complete metabolic panel with transaminases.
OTHERBody measurements
Participants will have their height, weight, waist circumference, and hip circumference measured.
OTHERQuestionnaires
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
Sponsors
Livivos, Inc.
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
National Institute for Biomedical Imaging and Bioengineering (NIBIB)
University of California, San Diego
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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®. |
| 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. |
Countries
United States
Outcome results
None listed