<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/NCT02207959</url>
  </required_header>
  <id_info>
    <org_study_id>GCO 09-0696B</org_study_id>
    <nct_id>NCT02207959</nct_id>
  </id_info>
  <brief_title>Gastric In Vivo Study</brief_title>
  <official_title>Endoscopic Multispectral Imaging for the Early Detection of Gastric Neoplasia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Susana Gonzalez</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>William Marsh Rice University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Icahn School of Medicine at Mount Sinai</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The overall objective of this pilot study is to determine whether multispectral imaging&#xD;
      increases the diagnostic accuracy of the current standard of high-definition white-light&#xD;
      endoscopy for the detection of gastric neoplasia (high grade dysplasia or cancer). As part of&#xD;
      an NCI-funded RO1, the investigators goal is to develop a multispectral endoscopic platform&#xD;
      that can be used to survey a large surface area and, potentially, serve as a &quot;red flag&quot; for&#xD;
      microendoscopic imaging of small areas. In prior ex vivo evaluations of surgical and&#xD;
      endoscopic specimens, the investigators have identified the optical settings and illumination&#xD;
      wavelengths that are complementary to white-light imaging and enhance superficial mucosal and&#xD;
      vascular changes associated with neoplasia. Based on this initial testing, vital-dye enhanced&#xD;
      fluorescence imaging (VFI) and imaging with High Resolution Microendoscope (HRME) have been&#xD;
      identified as modalities that may be complementary to white-light imaging. The goal of this&#xD;
      pilot study is to preliminarily determine the accuracy of these modalities during the&#xD;
      endoscopic surveillance and detection of gastric neoplasia.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Consent will be obtained the day of the subject's scheduled endoscopy in a clinical room or&#xD;
      at a routine office visit prior to the endoscopy. The study investigator will explain the&#xD;
      study including the reasons why subject may be eligible, risks, and benefits. The subject&#xD;
      will be given a chance to address any questions or concerns they may have.&#xD;
&#xD;
      If the patient agrees to participate in this study all of the procedures listed below will be&#xD;
      performed the day of the scheduled endoscopy exam. The procedures listed are part of the&#xD;
      routine standard of care for an endoscopy exam, except for the images that are being taken&#xD;
      and the additional 2-6 biopsies taken from any abnormal areas that are seen with the new&#xD;
      imaging technique. The use of the imaging technique described in this research study will not&#xD;
      change the standard of care procedures.&#xD;
&#xD;
      The endoscopic procedure is outlined below:&#xD;
&#xD;
        1. White Light Examination: Examination will initially be performed in the standard&#xD;
           white-light endoscopic mode as is routinely done. Abnormal gastric mucosa areas and&#xD;
           nodularities will be recorded. Any &quot;Suspicious&quot; areas (visible abnormalities, etc.) will&#xD;
           be photographed and the location recorded (distance from incisors and endoscopic&#xD;
           quadrant, eq. 34 cm; greater curvature, lesser curvature, etc).&#xD;
&#xD;
        2. Vital-Dye Enhanced Fluorescence Examination: Following this, the stomach will be sprayed&#xD;
           with 1-10 ml of 0.01% proflavine using a standard endoscopic spray-catheter. Using the&#xD;
           fluorescent imaging, the location of any VFI-&quot;Suspicious' areas will be recorded.&#xD;
           Additionally, VFI examination of any suspicious areas seen on WLE will be performed. The&#xD;
           endoscopist will label the surface-appearance of each WLE abnormal area based on its VFI&#xD;
           appearance. Thus, each area will be labeled as: &quot;Not Suspicious,&quot; or &quot;Suspicious for&#xD;
           Neoplasia.&quot;&#xD;
&#xD;
        3. HRME examination: WLE and VFI suspicious appearing areas will be further imaged with&#xD;
           HRME. HRME will be inserted through the biopsy channel of the endoscope, gently placed&#xD;
           against the mucosa, and images of suspicious areas will be obtained. The endoscopist&#xD;
           will label the surface-appearance of each WLE abnormal area and VFI abnormal area, based&#xD;
           on the HRME appearance. Thus, each area will be labeled as: &quot;Not Suspicious,&quot; or&#xD;
           &quot;Suspicious for Neoplasia.&quot;&#xD;
&#xD;
        4. Biopsy Protocol: Biopsies will be obtained of any area suspicious on any of the imaging&#xD;
           modalities (WLE, VFI or HRME). Additionally, two 'control' areas (normal on imaging)&#xD;
           will also be biopsied. Lastly, routine, biopsies will be performed per clinical care to&#xD;
           determine areas of intestinal metaplasia and H pylori infection as per routine standard&#xD;
           of care.&#xD;
&#xD;
        5. Pathologic Interpretation: All samples will be evaluated by a single expert&#xD;
           gastrointestinal pathologist who will be blinded to the endoscopic findings&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    PI left institution&#xD;
  </why_stopped>
  <start_date>January 2015</start_date>
  <completion_date type="Actual">June 2015</completion_date>
  <primary_completion_date type="Actual">June 2015</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Gastric neoplasia presence</measure>
    <time_frame>Day 1</time_frame>
    <description>Comparison of the efficiency of widefield imaging modality or combination of modalities (WLE, WLE+VFI/HRME for the highest accuracy on the detection of gastric neoplasia</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Sensitivity for the detection of neoplasia</measure>
    <time_frame>Day 1</time_frame>
    <description>the potential errors in estimation of sensitivity (true positive rate)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Specificity for the detection of neoplasia</measure>
    <time_frame>Day 1</time_frame>
    <description>the potential errors in estimation of specificity (true negative rate)</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">8</enrollment>
  <condition>Gastric Cancer</condition>
  <arm_group>
    <arm_group_label>Surveillance Endoscopy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>White light examination, vital-dye enhanced fluorescence examination (VFI), High Resolution Microendoscope (HRME)</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Proflavine Hemisulphate salt</intervention_name>
    <description>The stomach will be sprayed with 1-10 ml of 0.01% proflavine using a standard endoscopic spray-catheter.</description>
    <arm_group_label>Surveillance Endoscopy</arm_group_label>
    <other_name>Vital-dye enhanced fluorescence imaging</other_name>
    <other_name>VFI</other_name>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>White-light examination</intervention_name>
    <description>standard white light examination</description>
    <arm_group_label>Surveillance Endoscopy</arm_group_label>
    <other_name>White-light endoscopic examination</other_name>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Imaging with High Resolution Microendoscope</intervention_name>
    <description>HRME will be inserted through the biopsy channel of the endoscope, gently placed against the mucosa, and images of suspicious areas will be obtained.</description>
    <arm_group_label>Surveillance Endoscopy</arm_group_label>
    <other_name>HRME</other_name>
    <other_name>VFI/HRME</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patients with high grade dysplasia in the stomach and known or suspected cancer of the&#xD;
             stomach undergoing endoscopic surveillance&#xD;
&#xD;
          -  at least 18 years of age&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  subjects who report an allergy to Proflavine&#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>Susana Gonzalez, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Icahn School of Medicine at Mount Sinai</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Icahn School of Medicine at Mount Sinai</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10029</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2017</verification_date>
  <study_first_submitted>July 31, 2014</study_first_submitted>
  <study_first_submitted_qc>August 1, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 4, 2014</study_first_posted>
  <last_update_submitted>April 28, 2017</last_update_submitted>
  <last_update_submitted_qc>April 28, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">May 2, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Icahn School of Medicine at Mount Sinai</investigator_affiliation>
    <investigator_full_name>Susana Gonzalez</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <keyword>Gastric cancer</keyword>
  <keyword>Neoplasia</keyword>
  <keyword>Endoscopic imaging</keyword>
  <keyword>In vivo imaging</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Stomach Neoplasms</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Proflavine</mesh_term>
  </intervention_browse>
  <!-- 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/NCT02207959
org study id: GCO 09-0696B
nct id: NCT02207959
lead sponsor: 
collaborator: 
has dmc: No
The overall objective of this pilot study is to determine whether multispectral imaging
      increases the diagnostic accuracy of the current standard of high-definition white-light
      endoscopy for the detection of gastric neoplasia (high grade dysplasia or cancer). As part of
      an NCI-funded RO1, the investigators goal is to develop a multispectral endoscopic platform
      that can be used to survey a large surface area and, potentially, serve as a "red flag" for
      microendoscopic imaging of small areas. In prior ex vivo evaluations of surgical and
      endoscopic specimens, the investigators have identified the optical settings and illumination
      wavelengths that are complementary to white-light imaging and enhance superficial mucosal and
      vascular changes associated with neoplasia. Based on this initial testing, vital-dye enhanced
      fluorescence imaging (VFI) and imaging with High Resolution Microendoscope (HRME) have been
      identified as modalities that may be complementary to white-light imaging. The goal of this
      pilot study is to preliminarily determine the accuracy of these modalities during the
      endoscopic surveillance and detection of gastric neoplasia.
Consent will be obtained the day of the subject's scheduled endoscopy in a clinical room or
      at a routine office visit prior to the endoscopy. The study investigator will explain the
      study including the reasons why subject may be eligible, risks, and benefits. The subject
      will be given a chance to address any questions or concerns they may have.

      If the patient agrees to participate in this study all of the procedures listed below will be
      performed the day of the scheduled endoscopy exam. The procedures listed are part of the
      routine standard of care for an endoscopy exam, except for the images that are being taken
      and the additional 2-6 biopsies taken from any abnormal areas that are seen with the new
      imaging technique. The use of the imaging technique described in this research study will not
      change the standard of care procedures.

      The endoscopic procedure is outlined below:

        1. White Light Examination: Examination will initially be performed in the standard
           white-light endoscopic mode as is routinely done. Abnormal gastric mucosa areas and
           nodularities will be recorded. Any "Suspicious" areas (visible abnormalities, etc.) will
           be photographed and the location recorded (distance from incisors and endoscopic
           quadrant, eq. 34 cm; greater curvature, lesser curvature, etc).

        2. Vital-Dye Enhanced Fluorescence Examination: Following this, the stomach will be sprayed
           with 1-10 ml of 0.01% proflavine using a standard endoscopic spray-catheter. Using the
           fluorescent imaging, the location of any VFI-"Suspicious' areas will be recorded.
           Additionally, VFI examination of any suspicious areas seen on WLE will be performed. The
           endoscopist will label the surface-appearance of each WLE abnormal area based on its VFI
           appearance. Thus, each area will be labeled as: "Not Suspicious," or "Suspicious for
           Neoplasia."

        3. HRME examination: WLE and VFI suspicious appearing areas will be further imaged with
           HRME. HRME will be inserted through the biopsy channel of the endoscope, gently placed
           against the mucosa, and images of suspicious areas will be obtained. The endoscopist
           will label the surface-appearance of each WLE abnormal area and VFI abnormal area, based
           on the HRME appearance. Thus, each area will be labeled as: "Not Suspicious," or
           "Suspicious for Neoplasia."

        4. Biopsy Protocol: Biopsies will be obtained of any area suspicious on any of the imaging
           modalities (WLE, VFI or HRME). Additionally, two 'control' areas (normal on imaging)
           will also be biopsied. Lastly, routine, biopsies will be performed per clinical care to
           determine areas of intestinal metaplasia and H pylori infection as per routine standard
           of care.

        5. Pathologic Interpretation: All samples will be evaluated by a single expert
           gastrointestinal pathologist who will be blinded to the endoscopic findings
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Gastric neoplasia presence
time frame: Day 1
description: Comparison of the efficiency of widefield imaging modality or combination of modalities (WLE, WLE+VFI/HRME for the highest accuracy on the detection of gastric neoplasia
measure: Sensitivity for the detection of neoplasia
time frame: Day 1
description: the potential errors in estimation of sensitivity (true positive rate)
measure: Specificity for the detection of neoplasia
time frame: Day 1
description: the potential errors in estimation of specificity (true negative rate)
arm group label: Surveillance Endoscopy
arm group type: Experimental
description: White light examination, vital-dye enhanced fluorescence examination (VFI), High Resolution Microendoscope (HRME)
intervention type: Drug
intervention name: Proflavine Hemisulphate salt
description: The stomach will be sprayed with 1-10 ml of 0.01% proflavine using a standard endoscopic spray-catheter.
arm group label: Surveillance Endoscopy
other name: Vital-dye enhanced fluorescence imaging
other name: VFI
intervention type: Procedure
intervention name: White-light examination
description: standard white light examination
arm group label: Surveillance Endoscopy
other name: White-light endoscopic examination
intervention type: Procedure
intervention name: Imaging with High Resolution Microendoscope
description: HRME will be inserted through the biopsy channel of the endoscope, gently placed against the mucosa, and images of suspicious areas will be obtained.
arm group label: Surveillance Endoscopy
other name: HRME
other name: VFI/HRME
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Susana Gonzalez, MD
role: Principal Investigator
affiliation: Icahn School of Medicine at Mount Sinai
facility: 
country: United States
responsible party type: Sponsor-Investigator
investigator affiliation: Icahn School of Medicine at Mount Sinai
investigator full name: Susana Gonzalez
investigator title: Assistant Professor
mesh term: Stomach Neoplasms
mesh term: Proflavine