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| ID | Type | Description | Link |
|---|---|---|---|
| 1R43DK135225-01 | U.S. NIH Grant/Contract | View source | |
| 1R43EB034626-01A1 | 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 |
| National Institute for Biomedical Imaging and Bioengineering (NIBIB) | NIH |
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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:
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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. |
|
| 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 |
|---|---|---|
| Repeatability and reproducibility coefficients of LiverScope® PDFF measurements | Estimation of repeatability and reproducibility coefficients of liver PDFF values measured by LiverScope®. | 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. | Up to 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Repeatability and reproducibility coefficients of LiverScope® T1 measurements | Estimation of repeatability and reproducibility coefficients of liver T1 values estimated by LiverScope®. | Up to 3 months |
| Correlation coefficient between LiverScope® T1 and T2 measurements and MRS T1 and T2 measurements |
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Inclusion Criteria:
Exclusion Criteria:
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Adults with clinically known or suspected liver disease.
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| 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 | La Jolla | California | 92037 | United States |
This is an SBIR study. De-identified coded data will be shared as per grant application.
One year after completion
Public
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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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| FibroScan® exam (optional) | Diagnostic Test | Participants may undergo a FibroScan® exam (optional) to evaluate liver fat and liver stiffness. |
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| Blood draw | Other | Participants will undergo a blood draw (approximately 10 mL) for measurement of CBC, platelets, and complete metabolic panel with transaminases. |
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| Body measurements | Other | Participants will have their height, weight, waist circumference, and hip circumference measured. |
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| Questionnaires | Other | 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 |
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Estimation of the correlation coefficient between LiverScope® T1 and T2 measurements and MRS T1 and T2 measurements. |
| Up to 3 months |
| 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 |