NCT07518784 · University of California, San Diego
Accurate Point of Care Liver Disease Diagnostics (Phase 2)
What this study is about
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.
View original scientific description
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.
Interventions
DIAGNOSTIC_TEST
LiverScope® exam
Participants will undergo a LiverScope® examination to measure liver proton density fat fraction (PDFF, primary) and T1 and T2 values (exploratory).
DIAGNOSTIC_TEST
MR exam
Participants will undergo an advanced MR examination to measure liver PDFF, T1, T2, and liver stiffness values.
DIAGNOSTIC_TEST
Blood 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).
OTHER
Body measurements
Height, weight, waist circumference, and hip circumference will be measured.
OTHER
Questionnaire
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).
Primary outcome measures
Agreement of LiverScope® measurements compared to conventional MR
Time frame: Up to 3 months
Assessment of agreement between LiverScope® measurements and conventional MR measurements in the liver.
Repeatability and reproducibility of LiverScope® measurements
Time frame: Up to 3 months
Estimation of repeatability and reproducibility coefficients of liver measurements made by LiverScope®.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- La Jolla, California
Collaborators
Livivos, Inc., National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Apr 9, 2026 · Source of record for eligibility and locations