Thermoacoustic Method for Estimating Liver Fat Fraction
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
| Condition(s) | MASLD/MASH (Metabolic Dysfunction-Associated Steatotic Liver Disease / Metabolic Dysfunction-Associated Steatohepatitis), Fatty Liver Disease, Nonalcoholic |
|---|---|
| Status | Recruiting |
| Study type | Observational |
| Summary | 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. |
| Who can participate | Inclusion Criteria: * Study participants are 18 or older. * Able to understand, read, and provide written informed consent in English. * Able to tolerate both ultrasound and MRI examinations. * Able to lie flat, or on their side, for 20 minutes and pause breathing for up to 10 seconds. Exclusion Criteria: * Metal or electronic implants, including, but not limited to: pacemakers, metal clips, drug delivery pumps, hip implants, and neural stimulation devices, contraindicates for MRI. * Known pregnancy the day of consent or becoming pregnant during study participation based on start date of last menstrual period). * Liver diseases other than MASLD/MASH/fibrosis including, but not limited to: * Cirrhosis * Hepatocellular carcinoma * Ascites * Patients with broken, or injured skin, in the right |
| Ages | 18 Years |
| Sex | All |
| Accepts healthy volunteers | Yes |
| Lead sponsor | Endra Lifesciences |
| Locations | Ann Arbor, Michigan, United States |
| Start date | 2025-08-15 |
| NCT ID | NCT07321925 |
| Official listing | https://clinicaltrials.gov/study/NCT07321925 |