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| ID | Type | Description | Link |
|---|---|---|---|
| 2R44DK135225-02 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Livivos, Inc. | UNKNOWN |
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single arm | This is a single arm study in which all participants undergo the same research procedures. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LiverScope® exam | Diagnostic Test | Participants will undergo a LiverScope® examination to measure liver proton density fat fraction (PDFF, primary) and T1 and T2 values (exploratory). |
| Measure | Description | Time Frame |
|---|---|---|
| Agreement of LiverScope® measurements compared to conventional MR | Assessment of agreement between LiverScope® measurements and conventional MR measurements in the liver. | Up to 3 months |
| Repeatability and reproducibility of LiverScope® measurements | Estimation of repeatability and reproducibility coefficients of liver measurements made by LiverScope®. | Up to 3 months |
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| Measure | Description | Time Frame |
|---|---|---|
| Liver T1, T2, and stiffness measurements | 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. | Up to 3 months. |
Inclusion Criteria:
Exclusion Criteria:
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Adults with known or clinically suspected MASLD.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yesenia Covarrubias | Contact | 858-246-2198 | ycovarrubias@health.ucsd.edu | |
| Gage Tanzman | Contact | g1tanzman@health.ucsd.edu |
| Name | Affiliation | Role |
|---|---|---|
| Claude B Sirlin, MD | University of California, San Diego | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California San Diego | Recruiting | La Jolla | California | 92037 | United States |
This is an NIH SBIR study. De-identified coded data will be shared as per grant application.
One year after completion
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| ID | Term |
|---|---|
| D065626 | Non-alcoholic Fatty Liver Disease |
| ID | Term |
|---|---|
| D005234 | Fatty Liver |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D001800 | Blood Specimen Collection |
| D001837 | Body Weights and Measures |
| D011795 | Surveys and Questionnaires |
| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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| MR exam | Diagnostic Test | Participants will undergo an advanced MR examination to measure liver PDFF, T1, T2, and liver stiffness values. |
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| Blood draw | Diagnostic 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). |
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| Body measurements | Other | Height, weight, waist circumference, and hip circumference will be measured. |
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| Questionnaire | Other | 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). |
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| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |
| D001824 | Body Constitution |
| D010808 | Physical Examination |
| D000886 | Anthropometry |
| D010829 | Physiological Phenomena |
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |