NCT07321925

Thermoacoustic Method for Estimating Liver Fat Fraction

Thermoacoustic Method for Estimating Liver Fat Fraction - Pilot Study I

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 49 (estimated)
• Sponsor: Endra Lifesciences · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

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

Conditions

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

Interventions

Type	Name	Description
DEVICE	Thermoacoustic Enhanced Ultrasound	a novel Thermoacoustic Enhanced imaging device

Timeline

• Start date: 2025-08-15
• Primary completion: 2025-10-30
• Completion: 2025-12-31
• First posted: 2026-01-07
• Last updated: 2026-01-07

Locations

1 site across 1 country: United States