NCT07321925 · Endra Lifesciences
Thermoacoustic Method for Estimating Liver Fat Fraction
What this study 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.
View original scientific description
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
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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:
- Hepatocellular carcinoma
- 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
- Ann Arbor, Michigan
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jan 7, 2026 · Source of record for eligibility and locations