Thermoacoustic Method for Estimating Liver Fat Fraction

NCT07321925 | Recruiting

• 1 other identifier: ENDRA-CL25-01
• Study Type: observational
• Target: 49
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Keywords

Fatty Liver; MASLD; MASH; Thermoacoustic

Outcome Measures

Primary Outcomes (1)

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

  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.

Interventions

Thermoacoustic Enhanced Ultrasound DEVICE

a novel Thermoacoustic Enhanced imaging device

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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 may not qualify if:

• 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.

Sponsors & Collaborators

• Endra Lifesciences: lead

Study Sites (1)

ENDRA Life Sciences

Ann Arbor, Michigan, 48105, United States

RECRUITING

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease; Fatty Liver

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases

Central Study Contacts

Ziad Rouag

CONTACT

415-531-4647; zrouag@endrainc.com

Ava Ohlgren

CONTACT

734-315-0090; aohlgren@endrainc.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 11, 2025
• First Posted: January 7, 2026
• Study Start: August 15, 2025
• Primary Completion: October 30, 2025
• Study Completion: December 31, 2025
• Last Updated: January 7, 2026

Record last verified: 2025-12

Locations

US (1)