MASLD, MASLD (Metabolic Dysfunction-Associated Steatotic Liver Disease), NAFLD, NAFLD (Nonalcoholic Fatty Liver Disease)
Conditions
Brief summary
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
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_TESTBlood draw
A blood sample of approximately 10 mL will be collected for routine laboratory tests including complete blood count (CBC) and comprehensive metabolic panel (CMP).
OTHERBody measurements
Height, weight, waist circumference, and hip circumference will be measured.
OTHERQuestionnaire
A 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).
Sponsors
University of California, San Diego
Livivos, Inc.
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
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 * Known or clinically suspected MASLD * BMI greater than 27 kg/m\^2 and less than 45 kg/m\^2 at the time of referral * Ability to lie on LiverScope® device table for about 60 minutes * Ability to hold breath repeatedly for about 20 seconds during MR and LiverScope® exams * Willing and able to undergo all study procedures
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Agreement of LiverScope® measurements compared to conventional MR | Up to 3 months | Assessment of agreement between LiverScope® measurements and conventional MR measurements in the liver. |
| Repeatability and reproducibility of LiverScope® measurements | Up to 3 months | Estimation of repeatability and reproducibility coefficients of liver measurements made by LiverScope®. |
Countries
United States
Contacts
CONTACTYesenia Covarrubias
CONTACTGage Tanzman
PRINCIPAL_INVESTIGATORClaude B Sirlin, MD
University of California, San Diego
Outcome results
None listed