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The goal of this study is to use our Thermoacoustic Enhanced Ultrasound device to measure the fat levels in your liver and compare it to the the gold standard MRI PDFF measurements. Participants will have a scan with our device, then they will go have an abdominal MRI completed. The goal is to create a more accessible device to measure liver fat as it is an indicator for overall health and metabolic diseases.
The study will perform thermoacoustic fat measurements for up to 80 participants, over the span of the study. MRI-PDFF sequences will be acquired for participants in the study to establish a true measure of liver fat content, per the MRI gold standard. Determine the correlation between FLIP CID system Fat fraction results and the MRI-PDFF. Determine the accuracy between the fat measures obtained by the FLIP CID system participants who received a quantitative MRI. The following additional parameters will be evaluated endpoints: Sensitivity, Specificity ,Positive and negative predictive value (PPV, NPV) and The area under the ROC curve for the detection of liver fat abnormalities
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Thermoacoustic Enhanced Ultrasound | Device | a novel Thermoacoustic Enhanced imaging device |
| Measure | Description | Time Frame |
|---|---|---|
| Correlation between Thermoacoustic Fat Fraction (TAFF) and the MRI-PDFF | The correlation between TAFF and the MRI-PDFF, will be conducted using the calculation of the cumulative distribution of the correlation coefficient as derived by Guenther | From enrollment until the statistical analysis is reviewed, typically 2 weeks after last MRI data is received. |
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Inclusion Criteria:
Exclusion Criteria:
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Study Participants will be from the local general population with focus on potential study participants with known, or clinically suspected, elevated fatty liver
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ziad Rouag | Contact | 415-531-4647 | zrouag@endrainc.com | |
| Ava Ohlgren | Contact | 734-315-0090 | aohlgren@endrainc.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ENDRA Life Sciences | Recruiting | Ann Arbor | Michigan | 48105 | United States |
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| ID | Term |
|---|---|
| D065626 | Non-alcoholic Fatty Liver Disease |
| D005234 | Fatty Liver |
| ID | Term |
|---|---|
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
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