Fatty Liver Imaging Project

NCT03757832 | Completed

• 1 other identifier: 111117
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

This study is being done to test the FLIP device, a novel device developed and manufactured by Endra Life Sciences, located in Ann Arbor, Michigan. The purpose of the device is to measure the fat content of liver tissue to assist in the diagnosis of fatty liver disease. This feasibility study will involve 25 healthy volunteers having their liver imaged by traditional ultrasound and MRI methods as well as using the FLIP device. The data obtained by the FLIP will be compared with the data obtained by ultrasound and MRI in order to determine the effectiveness of the device. This is a preliminary study to see if the investigational device could eventually be used to image the liver alongside traditional ultrasound for discerning fat concentration.

Conditions

Determine the Number of Anatomical Sites at Which Successful Thermoacoustic Fat Measurements Can be Made From Five Acquisitions Using the FLIP ITA Device; Determine the Correlation of Fat Measures Obtained by the FLIP Device and Those Obtained From Quantitative MRI; Provide Insight Into the Sensitivity of Thermoacoustic Liver Fat Assessment With the Aim of Detecting Fat Content in Liver at 15% or Less, by Volume

Outcome Measures

Primary Outcomes (1)

• Fat concentration estimate

  The purpose of the device is to measure the fat content of liver tissue to assist in the diagnosis of fatty liver disease.

  September 2019

Interventions

Liver Imaging DEVICE

The device will acquire thermoacoustic data while the ultrasound probe acquires ultrasound images, and an MR of the liver is acquired as a comparative modality.

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

This feasibility study will recruit 25 healthy volunteers to undergo an ultrasound and thermoacoustic, and MRI examination of their liver while breathing normally, and during short breath-hold periods

You may qualify if:

• \- Healthy volunteers which represent a range of genders, age, BMI and lifestyle.
• Must be over the age of 18.
• Must be proficient in English (reading/writing).

You may not qualify if:

• \- Any metal or electronic implants including but not limited to pacemakers, metal clips, hips.
• Pregnancy

Sponsors & Collaborators

• Aaron Fenster: lead

Study Sites (1)

Aaron Fenster

London, Ontario, N6A 5B7, Canada

Location

Study Officials

• Aaron Fenster, PhD

  The University of Western Ontario

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Scientist

Study Record Dates

• First Submitted: November 27, 2018
• First Posted: November 29, 2018
• Study Start: September 20, 2018
• Primary Completion: August 8, 2023
• Study Completion: August 8, 2023
• Last Updated: August 15, 2023

Record last verified: 2023-08

Locations

CA (1)