Thermoacoustic Method for Estimating Liver Fat Fraction

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorEndra Lifesciences

About this trial

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 criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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).

Cirrhosis

Hepatocellular carcinoma

Trial population

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

Trial design

Design model

Other

Time perspective

Cross-sectional

Treatments tested in this trial

  • Thermoacoustic Enhanced Ultrasound

    Device

    a novel Thermoacoustic Enhanced imaging device

Treatment groups

No treatment groups listed

Trial outcomes

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

Time frame
From enrollment until the statistical analysis is reviewed, typically 2 weeks after last MRI data is received.

Secondary outcomes

Other outcomes

Sponsors and contacts

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