This research study is being conducted to find out more about techniques to non-invasively evaluate liver disease. This is the second phase of a project in which we are testing a new technology to evaluate the liver (LiverScope®). We will compare LiverScope® to other methods to evaluate the liver, including advanced conventional liver MR exams. MR exams are common exams used to monitor MASLD (also known as 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 second phase of the study, we took what we learned in the first phase to optimize the LiverScope® device and are now testing to see how LiverScope® measurements compare to MR after these optimizations.
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
Age ≥ 18 years
Known or clinically suspected MASLD
BMI greater than 27 kg/m² and less than 45 kg/m² at the time of referral
Ability to lie on LiverScope® device table for about 60 minutes
UCSD study personnel or Livivos study personne
Contraindications to MR
Potential participant states that she knows that she is pregnant, thinks she may be pregnant, or states that she is trying to become pregnant.
Known chronic liver disease other than MASLD
Adults with known or clinically suspected MASLD.
Cohort
Prospective
LiverScope® exam
Diagnostic testParticipants will undergo a LiverScope® examination to measure liver proton density fat fraction (PDFF, primary) and T1 and T2 values (exploratory).
MR exam
Diagnostic testParticipants will undergo an advanced MR examination to measure liver PDFF, T1, T2, and liver stiffness values.
Blood draw
Diagnostic testA blood sample of approximately 10 mL will be collected for routine laboratory tests including complete blood count (CBC) and comprehensive metabolic panel (CMP).
Body measurements
Other interventionHeight, weight, waist circumference, and hip circumference will be measured.
Questionnaire
Other interventionA questionnaire will be administered to collect demographic information (including age, sex, race, and ethnicity), and medical and social history (including alcohol use, tobacco use, history of diabetes, history of liver disease, and current medications).
Agreement of LiverScope® measurements compared to conventional MR
Assessment of agreement between LiverScope® measurements and conventional MR measurements in the liver.
Repeatability and reproducibility of LiverScope® measurements
Estimation of repeatability and reproducibility coefficients of liver measurements made by LiverScope®.
Liver T1, T2, and stiffness measurements
Using MR spectroscopy, T1 and T2 of liver tissue will be measured. Liver stiffness will be measured by MR Elastography. These data will enable confounder testing.
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University of California, San Diego
Lead sponsor
Livivos, Inc.
Collaborator
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborator
