MASLDNCT07518784
Accurate Point of Care Liver Disease Diagnostics (Phase 2)
An observational study of MASLD and MASLD (Metabolic Dysfunction-Associated Steatotic Liver Disease), run by University of California, San Diego at 1 site in United States.
Trial 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®). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- MASLD, MASLD (Metabolic Dysfunction-Associated Steatotic Liver Disease), NAFLD
- What is being tested?
- LiverScope® exam, MR exam and Blood draw
- How many people
- 26 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Apr 2026to 7 Aug 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults with known or clinically suspected MASLD.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California San Diego
La Jolla, California, 92037
About this study
Official title: Accurate Point of Care Liver Disease Diagnostics
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.
Read more
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
- Conditions
- MASLD, MASLD (Metabolic Dysfunction-Associated Steatotic Liver Disease), NAFLD, NAFLD (Nonalcoholic Fatty Liver Disease)
- Being tested
- LiverScope® exam, MR exam, Blood draw, Body measurements, Questionnaire
- Medical subject headings
- Non-alcoholic Fatty Liver Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LiverScope® examDiagnostic test
Participants will undergo a LiverScope® examination to measure liver proton density fat fraction (PDFF, primary) and T1 and T2 values (exploratory).
MR examDiagnostic test
Also called MRI, MRI exam
Participants will undergo an advanced MR examination to measure liver PDFF, T1, T2, and liver stiffness values.
Blood drawDiagnostic test
A blood sample of approximately 10 mL will be collected for routine laboratory tests including complete blood count (CBC) and comprehensive metabolic panel (CMP).
Body measurementsOther
Height, weight, waist circumference, and hip circumference will be measured.
QuestionnaireOther
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).
| Study group | Role | What they receive |
|---|---|---|
| Single arm | This is a single arm study in which all participants undergo the same research procedures. Receives: Diagnostic Test: LiverScope® exam; Diagnostic Test: MR exam; Diagnostic Test: Blood draw; Other: Body measurements; Other: Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Agreement of LiverScope® measurements compared to conventional MR
Assessment of agreement between LiverScope® measurements and conventional MR measurements in the liver.
Measured: Up to 3 months
Repeatability and reproducibility of LiverScope® measurements
Estimation of repeatability and reproducibility coefficients of liver measurements made by LiverScope®.
Measured: Up to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2026
- Study start8 Apr 2026
- Primary completion7 Aug 2026
- Study completion7 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MASLDStudies of the same condition, open and under way.
- More trials run by University of California, San DiegoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Collaborators
- Livivos, Inc., National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Responsible party
- Principal investigator, Claude Sirlin, University of California, San Diego
- Investigators
- Claude B Sirlin, MD, Principal investigator, University of California, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07518784
- Sponsor's protocol ID
- 814100
- Other IDs
- 2R44DK135225-02
- Status last verified
- Oct 2026
- First submitted
- 1 Apr 2026
- Last updated
- 2 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: This is an NIH SBIR study. De-identified coded data will be shared as per grant application.
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Accurate Point of Care Liver Disease Diagnostics
- ClinicalTrials.gov ID
- NCT07518784
- Acronym / sponsor ID
- 814100
- Conditions
- MASLD, MASLD (Metabolic Dysfunction-Associated Steatotic Liver Disease), NAFLD, NAFLD (Nonalcoholic Fatty Liver Disease)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Collaborators
- Livivos, Inc., National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 8 Apr 2026 (actual)
- Primary completion
- 7 Aug 2026 (actual)
- Study completion
- 7 Aug 2026 (actual)
- First posted
- 9 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single arm | – | Diagnostic Test: LiverScope® exam, Diagnostic Test: MR exam, Diagnostic Test: Blood draw, Other: Body measurements, Other: QuestionnaireThis is a single arm study in which all participants undergo the same research procedures. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults with known or clinically suspected MASLD.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LiverScope® examParticipants will undergo a LiverScope® examination to measure liver proton density fat fraction (PDFF, primary) and T1 and T2 values (exploratory). | Diagnostic test | Single arm |
| MR examAlso: MRI, MRI examParticipants will undergo an advanced MR examination to measure liver PDFF, T1, T2, and liver stiffness values. | Diagnostic test | Single arm |
| Blood drawA blood sample of approximately 10 mL will be collected for routine laboratory tests including complete blood count (CBC) and comprehensive metabolic panel (CMP). | Diagnostic test | Single arm |
| Body measurementsHeight, weight, waist circumference, and hip circumference will be measured. | Other | Single arm |
| QuestionnaireA 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). | Other | Single arm |
Primary outcome
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®.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2026.
- Individual participant dataSharing planned: Yes. This is an NIH SBIR study. De-identified coded data will be shared as per grant application.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Claude B Sirlin, MD principal investigator
University of California, San Diego
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of MASLD and MASLD (Metabolic Dysfunction-Associated Steatotic Liver Disease), run by University of California, San Diego at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Agreement of LiverScope® measurements compared to conventional MR (time frame: Up to 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2026.