University of California San Diego
La Jolla, California, 92037, United States
Location status: Recruiting
Location contact
Claude B Sirlin, MD
PRINCIPAL_INVESTIGATOR
Gage Tanzman
CONTACT
Yesenia Covarrubias
CONTACT
Recruiting
NCT Number: NCT07518784
Accurate Point of Care Liver Disease Diagnostics (Phase 2)
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
Recruiting
Interested in participating?
Request InfoKey information
Conditions
Age range
18 year and older
Sex eligibility
All sexes
Study type
Observational
Primary location
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
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.
Other names: MRI, MRI exam
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
OtherHeight, weight, waist circumference, and hip circumference will be measured.
Questionnaire
OtherA 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 outcomes
-
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®.
Other outcomes
-
Liver T1, T2, and stiffness measurements
Time frame: Up to 3 months.
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.
Study contacts
Contact information is provided by the study sponsor or research team.
Sponsors and collaborators
Lead sponsor
University of California, San Diego
Other
Collaborators
- Livivos, Inc.
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Registry information
Official study title
Accurate Point of Care Liver Disease Diagnostics
Important dates
- Study start
- 2026
- Primary completion
- 2026
- Study completion
- 2026
- First posted
- Apr 9, 2026
- Registry last updated
- Apr 9, 2026
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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