NAFLDNCT05986916
Accurate Point of Care Liver Disease Diagnostics
An observational study of NAFLD and Nonalcoholic Fatty Liver, 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. The investigators are testing a new technology to evaluate the liver (LiverScope®), and they will compare it to other methods to evaluate the liver, including advanced conventional liver MR and liver… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- NAFLD, Nonalcoholic Fatty Liver
- What is being tested?
- Liverscope® exam, MR exam and FibroScan® exam (optional)
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Aug 2023to Nov 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 clinically known or suspected liver disease.
Who may be able to join
- Age:18 years or older
- Known or clinically suspected NAFLD
- Weight less than 350 lbs (safety limit of MR scanner table)
- Able to lie on LiverScope® diagnostic table for about 15 min
- Able to hold breath repeatedly for about 20 s during MR and LiverScope® exams
- Willing and able to undergo all study procedures
Who cannot join
- VA patient only; not a UCSD patient
- UCSD or Livivos study personnel
- MR contraindication(s)
- Potential participant states that she knows that she is pregnant, thinks she may be pregnant or states she is trying to become pregnant*
- Known chronic liver disease other than NAFLD
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California San Diego
La Jolla, California, 92037
About this study
This research study is being conducted to find out more about techniques to non-invasively evaluate liver disease. The investigators are testing a new technology to evaluate the liver (LiverScope®), and they will compare it to other methods to evaluate the liver, including advanced conventional liver MR and liver FibroScan® ultrasound exams. MR exams and FibroScan® ultrasound exams are common exams used to monitor 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 study the investigators will learn how LiverScope® measurements of the liver compare to MR.
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
- NAFLD, Nonalcoholic Fatty Liver
- Being tested
- Liverscope® exam, MR exam, FibroScan® exam (optional), Blood draw, Body measurements
- 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
Participants will undergo an advanced MR examination to measure liver PDFF, T1, T2, and liver stiffness values.
FibroScan® exam (optional)Diagnostic test
Participants may undergo a FibroScan® exam (optional) to evaluate liver fat and liver stiffness.
Blood drawOther
Participants will undergo a blood draw (approximately 10 mL) for measurement of CBC, platelets, and complete metabolic panel with transaminases.
Body measurementsOther
Participants will have their height, weight, waist circumference, and hip circumference measured.
QuestionnairesOther
Participants will be asked to fill out questionnaires to collect information about their alcohol consumption, history of cigarette smoking, presence of diabetes, and history of liver disease and 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: FibroScan® exam (optional); Other: Blood draw; Other: Body measurements; Other: Questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
Repeatability and reproducibility coefficients of LiverScope® PDFF measurements
Estimation of repeatability and reproducibility coefficients of liver PDFF values measured by LiverScope®.
Measured: Up to 3 months
Agreement of LiverScope® PDFF measurements with MRI PDFF measurements
Assessment of the agreement between LiverScope® PDFF measurements and MRI PDFF measurements.
Measured: Up to 3 months
Secondary outcomes (2)
Repeatability and reproducibility coefficients of LiverScope® T1 measurements
Estimation of repeatability and reproducibility coefficients of liver T1 values estimated by LiverScope®.
Measured: Up to 3 months
Correlation coefficient between LiverScope® T1 and T2 measurements and MRS T1 and T2 measurements
Estimation of the correlation coefficient between LiverScope® T1 and T2 measurements and MRS T1 and T2 measurements.
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 posted14 Aug 2023
- Study start3 Aug 2023
- Primary completionNov 2025 (estimated)
- Study completionNov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NAFLDStudies 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
- 50 participants (estimated)
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), National Institute for Biomedical Imaging and Bioengineering (NIBIB)
- 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
- NCT05986916
- Sponsor's protocol ID
- 806222
- Other IDs
- 1R43DK135225-01, 1R43EB034626-01A1
- Status last verified
- Oct 2025
- First submitted
- 1 Aug 2023
- Last updated
- 23 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: This is an 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 23 Oct 2025. 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
- NCT05986916
- Acronym / sponsor ID
- 806222
- Conditions
- NAFLD, Nonalcoholic Fatty Liver
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Collaborators
- Livivos, Inc., National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), National Institute for Biomedical Imaging and Bioengineering (NIBIB)
- Study start
- 3 Aug 2023 (actual)
- Primary completion
- Nov 2025 (estimated)
- Study completion
- Nov 2025 (estimated)
- First posted
- 14 Aug 2023 (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. The investigators are testing a new technology to evaluate the liver (LiverScope®), and they will compare it to other methods to evaluate the liver, including advanced conventional liver MR and liver FibroScan® ultrasound exams. MR exams and FibroScan® ultrasound exams are common exams used to monitor 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 study the investigators will learn how LiverScope® measurements of the liver compare to MR.
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: FibroScan® exam (optional), Other: Blood draw, Other: Body measurements, Other: QuestionnairesThis 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 clinically known or suspected liver disease.
Key inclusion criteria (6 listed)
- Age:18 years or older
- Known or clinically suspected NAFLD
- Weight less than 350 lbs (safety limit of MR scanner table)
- Able to lie on LiverScope® diagnostic table for about 15 min
- Able to hold breath repeatedly for about 20 s during MR and LiverScope® exams
Key exclusion criteria (5 listed)
- VA patient only; not a UCSD patient
- UCSD or Livivos study personnel
- MR contraindication(s)
- Potential participant states that she knows that she is pregnant, thinks she may be pregnant or states she is trying to become pregnant*
- Known chronic liver disease other than NAFLD
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 examParticipants will undergo an advanced MR examination to measure liver PDFF, T1, T2, and liver stiffness values. | Diagnostic test | Single arm |
| FibroScan® exam (optional)Participants may undergo a FibroScan® exam (optional) to evaluate liver fat and liver stiffness. | Diagnostic test | Single arm |
| Blood drawParticipants will undergo a blood draw (approximately 10 mL) for measurement of CBC, platelets, and complete metabolic panel with transaminases. | Other | Single arm |
| Body measurementsParticipants will have their height, weight, waist circumference, and hip circumference measured. | Other | Single arm |
| QuestionnairesParticipants will be asked to fill out questionnaires to collect information about their alcohol consumption, history of cigarette smoking, presence of diabetes, and history of liver disease and medications | Other | Single arm |
Primary outcome
Repeatability and reproducibility coefficients of LiverScope® PDFF measurements
Time frame: Up to 3 months
Estimation of repeatability and reproducibility coefficients of liver PDFF values measured by LiverScope®.
Agreement of LiverScope® PDFF measurements with MRI PDFF measurements
Time frame: Up to 3 months
Assessment of the agreement between LiverScope® PDFF measurements and MRI PDFF measurements.
2 secondary outcomes
Repeatability and reproducibility coefficients of LiverScope® T1 measurements
Time frame: Up to 3 months
Correlation coefficient between LiverScope® T1 and T2 measurements and MRS T1 and T2 measurements
Time frame: Up to 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2025.
- Individual participant dataSharing planned: Yes. This is an 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 NAFLD and Nonalcoholic Fatty Liver, 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 5 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: under way, not looking for participants, as of the sponsor's last update on 23 Oct 2025. 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?
This study is still under way. Results are not available in the source record yet.
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?
Repeatability and reproducibility coefficients of LiverScope® PDFF measurements (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 23 Oct 2025.