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Recruiting Observational

Thermoacoustic Method for Estimating Liver Fat Fraction

NCT07321925 · tracked via the Priya Life Science USA tracker
Sponsor
Endra Lifesciences
Phase
Observational
Started
2025-08-15
Last updated
2026-01-07

Condition(s) studied

MASLD/MASH (Metabolic Dysfunction-Associated Steatotic Liver Disease / Metabolic Dysfunction-Associated Steatohepatitis)Fatty Liver Disease, Nonalcoholic

Investigational drug(s) / intervention(s)

Thermoacoustic Enhanced Ultrasound

Thermoacoustic Enhanced Ultrasound: a novel Thermoacoustic Enhanced imaging device

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
Accepted
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.

Primary outcome measure(s)

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

Trial sites (1)

FacilityCityRegionStatus
ENDRA Life Sciences Ann Arbor Michigan Recruiting

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07321925 on ClinicalTrials.gov ↗ ← All trials in the USA