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Fatty Liver Imaging Project (FLIP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03757832
Recruitment Status : Recruiting
First Posted : November 29, 2018
Last Update Posted : November 29, 2018
Information provided by (Responsible Party):
Aaron Fenster, Western University, Canada

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.

Condition or disease Intervention/treatment
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 Device: Liver Imaging

Detailed Description:

It has been demonstrated that thermoacoustic imaging can be used to identify water and fat concentrations [Bauer, 2012]. In addition, the group led by Dr. Kruger have demonstrated that conventional computed tomography shows similar features to thermoacoustic imaging in small animal studies [Kruger, 2003]. These concepts have led Endra Life Sciences to develop the FLIP device with the purpose of imaging fat concentration in liver tissue with indications for fatty liver disease. Non-alcoholic fatty liver disease (NAFLD) was first reported in 1980 by pathologists at the Mayo clinic in obese, or overweight, patients with no history of alcohol abuse. This represented the first time that fatty livers were observed with no history of alcohol abuse. Since that first report of NAFLD, increased rates of obesity and general increased caloric intake has dramatically increased rates of fatty liver disease. Estimates of NAFLD range from 25 - 40% of the adult population globally. NAFLD is a multi-system disease. Fatty liver disease is highly correlated with obesity and alcohol abuse, and is an important biomarker of insulin resistance and metabolic disease. Endra's technology offers a non-invasive, cost effective point of care solution to monitoring liver fat content that will be enormously helpful in surveilling patients with metabolic disease, insulin resistance, and those at risk for later stage liver disease.

This study will provide additional information that will guide the further development of the FLIP device with the end goal of commercializing the product. Fibroscan is a device that is currently on the market that is also indicated for fatty liver disease. Fibroscan is a shear wave elastography device that measures the stiffness of liver tissue by mechanically deforming tissue (by utilizing a plunger that vibrates the surface of the skin) and measures the resulting shear wave speed within the liver by ultrasound. The shear wave speed is related to the mechanical stiffness of the tissue. Fibroscan aims to assess the progression of infiltration of collagen into normal liver tissue that results in scarring, characteristic of fibrotic liver disease. Liver fibrosis progresses from fatty liver disease, not all fatty liver disease patients develop fibrotic liver disease.

The Fibroscan device has an optional software module that attempts to quantify the attenuation of the shear wave as it travels away from the plane of deformation. Fibroscan refers to this measurement as CAP (Calculated Attenuation Parameter). The attenuation of the shear wave is thought to be related to the degree of liver steatosis (fat content). To date, the technique has demonstrated poor sensitivity, and is poorly correlated with quantitative MRI measures of liver fat. Furthermore, CAP measurements in obese patients are difficult to obtain and unreliable . Endra's technology aims to provide much more sensitive measurements of liver fat content at the point of care. The Endra device has the potential to quantify fat content as low as 5% (by volume). The system is interoperable with ultrasound and leverages B-mode ultrasound imaging to guide measurement location. Compared to Fibroscan's CAP, Endra's fatty liver measures are expected to be much more sensitive and reproducible based on anatomical guidance by ultrasound imaging.

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Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Feasibility Study to Estimate Fat Concentration of Liver in Adults Through RF Imaging
Actual Study Start Date : September 20, 2018
Estimated Primary Completion Date : September 20, 2019
Estimated Study Completion Date : September 20, 2019

Resource links provided by the National Library of Medicine

Intervention Details:
  • Device: Liver Imaging
    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.

Primary Outcome Measures :
  1. Fat concentration estimate [ Time Frame: September 2019 ]
    The purpose of the device is to measure the fat content of liver tissue to assist in the diagnosis of fatty liver disease.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Inclusion Criteria:

  • - 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).

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03757832

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Contact: Aaron Fenster, PhD 519-931-5777 ext 5199315777
Contact: David Tessier, PhD 5199315777 ext 24196

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Canada, Ontario
Aaron Fenster Recruiting
London, Ontario, Canada, N6A 5B7
Contact: Aaron Fenster    5199315777 ext 5199315777   
Sponsors and Collaborators
Aaron Fenster
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Principal Investigator: Aaron Fenster, PhD University of Western Ontario, Canada

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Responsible Party: Aaron Fenster, Scientist, Western University, Canada Identifier: NCT03757832     History of Changes
Other Study ID Numbers: 111117
First Posted: November 29, 2018    Key Record Dates
Last Update Posted: November 29, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Immune System Diseases
Liver Extracts