<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03757832</url>
  </required_header>
  <id_info>
    <org_study_id>111117</org_study_id>
    <nct_id>NCT03757832</nct_id>
  </id_info>
  <brief_title>Fatty Liver Imaging Project</brief_title>
  <acronym>FLIP</acronym>
  <official_title>Feasibility Study to Estimate Fat Concentration of Liver in Adults Through RF Imaging</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Aaron Fenster</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Western University, Canada</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study is being done to test the FLIP device, a novel device developed and manufactured&#xD;
      by Endra Life Sciences, located in Ann Arbor, Michigan. The purpose of the device is to&#xD;
      measure the fat content of liver tissue to assist in the diagnosis of fatty liver disease.&#xD;
      This feasibility study will involve 25 healthy volunteers having their liver imaged by&#xD;
      traditional ultrasound and MRI methods as well as using the FLIP device. The data obtained by&#xD;
      the FLIP will be compared with the data obtained by ultrasound and MRI in order to determine&#xD;
      the effectiveness of the device. This is a preliminary study to see if the investigational&#xD;
      device could eventually be used to image the liver alongside traditional ultrasound for&#xD;
      discerning fat concentration.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      It has been demonstrated that thermoacoustic imaging can be used to identify water and fat&#xD;
      concentrations [Bauer, 2012]. In addition, the group led by Dr. Kruger have demonstrated that&#xD;
      conventional computed tomography shows similar features to thermoacoustic imaging in small&#xD;
      animal studies [Kruger, 2003]. These concepts have led Endra Life Sciences to develop the&#xD;
      FLIP device with the purpose of imaging fat concentration in liver tissue with indications&#xD;
      for fatty liver disease. Non-alcoholic fatty liver disease (NAFLD) was first reported in 1980&#xD;
      by pathologists at the Mayo clinic in obese, or overweight, patients with no history of&#xD;
      alcohol abuse. This represented the first time that fatty livers were observed with no&#xD;
      history of alcohol abuse. Since that first report of NAFLD, increased rates of obesity and&#xD;
      general increased caloric intake has dramatically increased rates of fatty liver disease.&#xD;
      Estimates of NAFLD range from 25 - 40% of the adult population globally. NAFLD is a&#xD;
      multi-system disease. Fatty liver disease is highly correlated with obesity and alcohol&#xD;
      abuse, and is an important biomarker of insulin resistance and metabolic disease. Endra's&#xD;
      technology offers a non-invasive, cost effective point of care solution to monitoring liver&#xD;
      fat content that will be enormously helpful in surveilling patients with metabolic disease,&#xD;
      insulin resistance, and those at risk for later stage liver disease.&#xD;
&#xD;
      This study will provide additional information that will guide the further development of the&#xD;
      FLIP device with the end goal of commercializing the product. Fibroscan is a device that is&#xD;
      currently on the market that is also indicated for fatty liver disease. Fibroscan is a shear&#xD;
      wave elastography device that measures the stiffness of liver tissue by mechanically&#xD;
      deforming tissue (by utilizing a plunger that vibrates the surface of the skin) and measures&#xD;
      the resulting shear wave speed within the liver by ultrasound. The shear wave speed is&#xD;
      related to the mechanical stiffness of the tissue. Fibroscan aims to assess the progression&#xD;
      of infiltration of collagen into normal liver tissue that results in scarring, characteristic&#xD;
      of fibrotic liver disease. Liver fibrosis progresses from fatty liver disease, not all fatty&#xD;
      liver disease patients develop fibrotic liver disease.&#xD;
&#xD;
      The Fibroscan device has an optional software module that attempts to quantify the&#xD;
      attenuation of the shear wave as it travels away from the plane of deformation. Fibroscan&#xD;
      refers to this measurement as CAP (Calculated Attenuation Parameter). The attenuation of the&#xD;
      shear wave is thought to be related to the degree of liver steatosis (fat content). To date,&#xD;
      the technique has demonstrated poor sensitivity, and is poorly correlated with quantitative&#xD;
      MRI measures of liver fat. Furthermore, CAP measurements in obese patients are difficult to&#xD;
      obtain and unreliable . Endra's technology aims to provide much more sensitive measurements&#xD;
      of liver fat content at the point of care. The Endra device has the potential to quantify fat&#xD;
      content as low as 5% (by volume). The system is interoperable with ultrasound and leverages&#xD;
      B-mode ultrasound imaging to guide measurement location. Compared to Fibroscan's CAP, Endra's&#xD;
      fatty liver measures are expected to be much more sensitive and reproducible based on&#xD;
      anatomical guidance by ultrasound imaging.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 20, 2018</start_date>
  <completion_date type="Actual">August 8, 2023</completion_date>
  <primary_completion_date type="Actual">August 8, 2023</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Fat concentration estimate</measure>
    <time_frame>September 2019</time_frame>
    <description>The purpose of the device is to measure the fat content of liver tissue to assist in the diagnosis of fatty liver disease.</description>
  </primary_outcome>
  <enrollment type="Actual">50</enrollment>
  <condition>Determine the Number of Anatomical Sites at Which Successful Thermoacoustic Fat Measurements Can be Made From Five Acquisitions Using the FLIP ITA Device</condition>
  <condition>Determine the Correlation of Fat Measures Obtained by the FLIP Device and Those Obtained From Quantitative MRI</condition>
  <condition>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</condition>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Liver Imaging</intervention_name>
    <description>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.</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        This feasibility study will recruit 25 healthy volunteers to undergo an ultrasound and&#xD;
        thermoacoustic, and MRI examination of their liver while breathing normally, and during&#xD;
        short breath-hold periods&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  - Healthy volunteers which represent a range of genders, age, BMI and lifestyle.&#xD;
&#xD;
          -  Must be over the age of 18.&#xD;
&#xD;
          -  Must be proficient in English (reading/writing).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  - Any metal or electronic implants including but not limited to pacemakers, metal&#xD;
             clips, hips.&#xD;
&#xD;
          -  Pregnancy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Aaron Fenster, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>The University of Western Ontario</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Aaron Fenster</name>
      <address>
        <city>London</city>
        <state>Ontario</state>
        <zip>N6A 5B7</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>August 2023</verification_date>
  <study_first_submitted>November 27, 2018</study_first_submitted>
  <study_first_submitted_qc>November 27, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 29, 2018</study_first_posted>
  <last_update_submitted>August 12, 2023</last_update_submitted>
  <last_update_submitted_qc>August 12, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">August 15, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Western University, Canada</investigator_affiliation>
    <investigator_full_name>Aaron Fenster</investigator_full_name>
    <investigator_title>Scientist</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hypersensitivity</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03757832
org study id: 111117
nct id: NCT03757832
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
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.
observational model: Cohort
time perspective: Prospective
measure: Fat concentration estimate
time frame: September 2019
description: The purpose of the device is to measure the fat content of liver tissue to assist in the diagnosis of fatty liver disease.
intervention type: Device
intervention name: Liver Imaging
description: 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.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Aaron Fenster, PhD
role: Principal Investigator
affiliation: The University of Western Ontario
facility: 
country: Canada
responsible party type: Sponsor-Investigator
investigator affiliation: Western University, Canada
investigator full name: Aaron Fenster
investigator title: Scientist
mesh term: Hypersensitivity
sharing ipd: Undecided