Actively Recruiting
Thermoacoustic Method for Estimating Liver Fat Fraction - Pilot Study I
Led by Endra Lifesciences · Updated on 2026-01-07
49
Participants Needed
1
Research Sites
8 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating a new Thermoacoustic Enhanced Ultrasound device to measure liver fat levels and compare its results to the current gold standard, MRI PDFF measurements. The study aims to develop a more accessible method for assessing liver fat, which is an important indicator for overall health and metabolic diseases such as MASLD/MASH and nonalcoholic fatty liver disease. Participants will undergo a scan using the Thermoacoustic Enhanced Ultrasound device, followed by an abdominal MRI to obtain MRI-PDFF sequences. The study will assess the correlation and accuracy between fat measurements from the Thermoacoustic device and MRI, as well as evaluate sensitivity, specificity, predictive values, and the area under the ROC curve for detecting liver fat abnormalities. During the study, participants will have both imaging procedures and must be able to tolerate ultrasound and MRI scans. Researchers will measure the correlation between the Thermoacoustic Fat Fraction and MRI-PDFF from enrollment until analysis is complete, about two weeks after the last MRI data is received. The total study involves up to 80 participants with regular evaluations to ensure data accuracy and safety.
CONDITIONS
Brief Title
Thermoacoustic Method for Estimating Liver Fat Fraction
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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.
You will not qualify if you...
- Metal or electronic implants, including pacemakers, metal clips, drug delivery pumps, hip implants, and neural stimulation devices, contraindicated for MRI.
- Known pregnancy at consent or becoming pregnant during study participation.
- Liver diseases other than MASLD/MASH/fibrosis, including cirrhosis, hepatocellular carcinoma, or ascites.
- Broken or injured skin in the right upper abdominal quadrant.
- Body habitus or anatomical variations preventing ultrasound access to the liver capsule through the right intercostal imaging window.
- BMI greater than 50 kg/m2.
- Subcutaneous fat at measurement location less than or equal to 6mm.
- Missing liver lobe.
- Peri-hepatic fat in the measurement location.
- Focal liver lesions or anatomical structures in the measurement location as detected by ultrasound.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 2 weeks
Participants undergo thermoacoustic enhanced ultrasound and quantitative MRI to measure liver fat content.
1 to 2 visits depending on imaging scheduling
Duration - Typically 2 weeks after last MRI data is received
Participants are observed while data analysis is performed to determine correlation and accuracy of liver fat measurements.
No visits required during monitoring
Trial Site Locations
Total: 1 location
1
ENDRA Life Sciences
Ann Arbor, Michigan, United States, 48105
Actively Recruiting
Research Team
Z
Ziad Rouag
A
Ava Ohlgren
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here