Thermoacoustic Method for Estimating Liver Fat Fraction

This study is looking at a new way to measure fat in the liver using a device called Thermoacoustic Enhanced Ultrasound. This device aims to be a more accessible way to check for liver fat, which is important for overall health and conditions like MASLD/MASH (Metabolic Dysfunction-Associated Steatotic Liver Disease / Metabolic Dysfunction-Associated Steatohepatitis), also known as fatty liver disease. Researchers will compare the results from the Thermoacoustic Enhanced Ultrasound device to a standard MRI scan (MRI-PDFF) to see how well they match. You can join if you are 18 or older, can understand English, and can comfortably have both ultrasound and MRI scans. The study is currently unclear about its recruitment status and plans to enroll up to 49 participants.

Study design
This is an observational study, meaning participants will not receive an experimental treatment. It aims to enroll up to 49 participants to compare a new imaging device with a standard MRI.
What's involved
You would have a scan with the Thermoacoustic Enhanced Ultrasound device, followed by an abdominal MRI. You need to be able to lie flat or on your side for 20 minutes and hold your breath for up to 10 seconds.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint, correlation between the two measurement methods, will be reviewed typically 2 weeks after the last MRI data is received.

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NCT07321925

Thermoacoustic Method for Estimating Liver Fat Fraction

Recruiting
Not specifiedAges 18+Observational
Endra Lifesciences
~49 participants
Updated 2026-01-07 on ClinicalTrials.gov
What's tested:Thermoacoustic Enhanced Ultrasound

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Correlation between Thermoacoustic Fat Fraction (TAFF) and the MRI-PDFF
Measured over From enrollment until the statistical analysis is reviewed, typically 2 weeks after last MRI data is received.
MASLD/MASH (Metabolic Dysfunction-Associated Steatotic Liver Disease / Metabolic Dysfunction-Associated Steatohepatitis)
Fatty Liver Disease, Nonalcoholic

NCT07321925

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • ENDRA Life Sciences

    Ann Arbor, Michiganstudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

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Eligibility criteria

Inclusion

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

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.
  • Correlation between Thermoacoustic Fat Fraction (TAFF) and the MRI-PDFFFrom enrollment until the statistical analysis is reviewed, typically 2 weeks after last MRI data is received.

    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