Thermoacoustic Method for Estimating Liver Fat Fraction
Recruiting · NCT07321925 · Observational (researchers observe without assigning treatment) · Lead sponsor: Endra Lifesciences
View the official record on ClinicalTrials.gov →Interventions studied
Thermoacoustic Enhanced Ultrasound
What this trial is about
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 take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
Yes - healthy volunteers may be accepted
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
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 upper abdominal quadrant.
- Body habitus, or anatomical variation, where the liver capsule is not accessible with ultrasound through the patient's right intercostal imaging window used in conventional ultrasound liver imaging.
- BMI greater than 50 kg/m2
- Patients with subcutaneous fat at measurement location less than or equal to 6mm.
- Patients with a missing liver lobe.
- Patients with peri-hepatic fat in the measurement location.
- Patients with focal liver lesions or anatomical structures in the measurement location, as detected by ultrasound.
Where it is running
1 location listed across 1 US state.
- ENDRA Life Sciences - Ann Arbor, Michigan, United States