RecruitingNot Applicable

Thermoacoustic Method for Estimating Liver Fat Fraction

United States49 participantsStarted 2025-08-15

Plain-language 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

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Correlation between Thermoacoustic Fat Fraction (TAFF) and the MRI-PDFF

Timeframe: From enrollment until the statistical analysis is reviewed, typically 2 weeks after last MRI data is received.

Trial details

NCT IDNCT07321925

SponsorEndra Lifesciences

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2025-10-30

Contact for this trial

Ziad Rouag

415-531-4647 zrouag@endrainc.com

View on ClinicalTrials.gov More MASLD/MASH (Metabolic Dysfunction-Associated Steatotic Liver Disease / Metabolic Dysfunction-Associated Steatohepatitis) trials