Thermoacoustic Method for Estimating Liver Fat Fraction

January 5, 2026 updated by: Endra Lifesciences

Thermoacoustic Method for Estimating Liver Fat Fraction - Pilot Study I

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The study will perform thermoacoustic fat measurements for up to 80 participants, over the span of the study. MRI-PDFF sequences will be acquired for participants in the study to establish a true measure of liver fat content, per the MRI gold standard. Determine the correlation between FLIP CID system Fat fraction results and the MRI-PDFF. Determine the accuracy between the fat measures obtained by the FLIP CID system participants who received a quantitative MRI. The following additional parameters will be evaluated endpoints: Sensitivity, Specificity ,Positive and negative predictive value (PPV, NPV) and The area under the ROC curve for the detection of liver fat abnormalities

Study Type

Observational

Enrollment (Estimated)

49

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Study Participants will be from the local general population with focus on potential study participants with known, or clinically suspected, elevated fatty liver

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Correlation between Thermoacoustic Fat Fraction (TAFF) and the MRI-PDFF
Time Frame: 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
From enrollment until the statistical analysis is reviewed, typically 2 weeks after last MRI data is received.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Endra Lifesciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 15, 2025

Primary Completion (Actual)

October 30, 2025

Study Completion (Estimated)

December 31, 2025

Study Registration Dates

First Submitted

December 11, 2025

First Submitted That Met QC Criteria

January 5, 2026

First Posted (Actual)

January 7, 2026

Study Record Updates

Last Update Posted (Actual)

January 7, 2026

Last Update Submitted That Met QC Criteria

January 5, 2026

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ENDRA-CL25-01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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