<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/NCT02251639</url>
  </required_header>
  <id_info>
    <org_study_id>2012-0887</org_study_id>
    <secondary_id>NCI-2014-02105</secondary_id>
    <secondary_id>RO1 910576</secondary_id>
    <secondary_id>960113</secondary_id>
    <nct_id>NCT02251639</nct_id>
  </id_info>
  <brief_title>Diagnostic Aids for Detection and Diagnosis of Oral Cancer</brief_title>
  <official_title>Evaluation of Diagnostic Aids for Detection and Diagnosis of Oral Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>M.D. Anderson Cancer Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institutes of Health (NIH)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
    <collaborator>
      <agency>William Marsh Rice University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>M.D. Anderson Cancer Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The goal of this clinical study is to find out if certain instruments/devices, such as wide&#xD;
      field fluorescence imaging point spectroscopy and/or brush cytology, can help health care&#xD;
      providers find mouth cancer more quickly than a standard oral clinical exam.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Study Procedures:&#xD;
&#xD;
      Certain types of light may cause cells to give off a tiny amount of light (called&#xD;
      fluorescence). Researchers have learned that cancer cells and normal cells reflect light and&#xD;
      give off fluorescence differently. Researchers want to find out if different kinds of light&#xD;
      can be used to discover areas of the mouth that may have abnormal or cancerous cells.&#xD;
&#xD;
      If you agree to take part in this study, a researcher may use up to 3 types of imaging&#xD;
      instruments to take pictures and readings of several areas in your mouth.&#xD;
&#xD;
        -  VELScope is an FDA approved handheld camera device that takes images of the mouth with&#xD;
           different colors of light. The VELScope shines blue light into the mouth, and pictures&#xD;
           are taken using a camera that is attached to the device.&#xD;
&#xD;
        -  Widefield Fluorescence Imaging uses a non-contact imaging device similar to the&#xD;
           VELScope. It shines different colors of light and then takes pictures of the inside of&#xD;
           the mouth using a digital camera.&#xD;
&#xD;
        -  Point Spectroscopy System uses a probe (about the size of a tip of a pen) that is gently&#xD;
           placed on several areas of the mouth. Different colors of light are directed through&#xD;
           optic fibers to the lining of the mouth, and the probe collects the light that returns&#xD;
           from the tissue and sends the information to a computer.&#xD;
&#xD;
      Researchers will record whether the doctors find any areas within your mouth that may not&#xD;
      appear completely normal. They will collect tissue samples of these abnormal areas using a&#xD;
      brush biopsy. To perform an oral brush biopsy, the research will press a small brush against&#xD;
      an area inside your mouth, and turn it 5-10 times. The areas that could be biopsied include&#xD;
      your gums, tongue, the roof of your mouth, the bottom of your mouth, or the inside of your&#xD;
      cheeks. Any cells collected from the inside of your mouth will be placed on slides to be&#xD;
      studied by the study team.&#xD;
&#xD;
      The samples being collected will only be used for this testing, and no leftover samples will&#xD;
      be kept by the research staff.&#xD;
&#xD;
      These procedures should take about 20 minutes total.&#xD;
&#xD;
      This is an investigational study. The VELScope is an FDA approved device and is commercially&#xD;
      available. Wide-field and point spectroscopy systems are not FDA approved and are only&#xD;
      authorized for research. Up to 500 participants will take part in this multicenter study. Up&#xD;
      to 250 will be enrolled at MD Anderson.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    Study design improvements.&#xD;
  </why_stopped>
  <start_date type="Actual">October 2014</start_date>
  <completion_date type="Anticipated">October 2020</completion_date>
  <primary_completion_date type="Anticipated">October 2020</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>Performance of the POS, PS2 and VELscope as Diagnostic Aid for Oral Cancer</measure>
    <time_frame>1 day</time_frame>
    <description>Information obtained from the fluorescence and reflectance images, point spectroscopy, and oral cytology compared with clinical diagnosis to evaluate the performance of the diagnostic aids and assess any clinical benefit to assist in screening for oral cancer. ROC curve analysis used as primary method for evaluating the performance of the POS, PS2 and VELscope devices as compared to the white light standard clinical diagnosis.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Head and Neck Cancer</condition>
  <arm_group>
    <arm_group_label>Oral Imaging and Cytology</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participant completes a short questionnaire regarding their awareness of oral cancer and risk factors. Oral cavity inspected using a standard white light headlamp. Oral cavity then examined with one or more of the widefield imaging devices, such as the VELscope and/or PS2 device. Exfoliative cells for cytology from an abnormal area (if present) and from a contralateral normal appearing area obtained using a brush.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Questionnaire</intervention_name>
    <description>Participant completes a short questionnaire regarding their awareness of oral cancer and risk factors.</description>
    <arm_group_label>Oral Imaging and Cytology</arm_group_label>
    <other_name>Survey</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>POS + PS2 + VELscope</intervention_name>
    <description>Oral cavity examined with one or more of the widefield imaging devices, such as the VELscope and/or PS2 device.</description>
    <arm_group_label>Oral Imaging and Cytology</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Oral Brush Biopsy</intervention_name>
    <description>If abnormal areas found, a small brush is pressed against an area inside mouth, and turned 5-10 times. The areas that could be biopsied include gums, tongue, roof of mouth, bottom of mouth, or the inside of cheeks.</description>
    <arm_group_label>Oral Imaging and Cytology</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Subjects 18 years and older who are willing to participate.&#xD;
&#xD;
          2. Persons presenting for: Physical or dental exams at outside health care centers OR&#xD;
             Research meetings/gatherings OR Subjects identified at MDACC who are not already&#xD;
             diagnosed with oral cancer or pre oral cancer: this includes patients with&#xD;
             malignancies other than oral cancer, and visitors and family members, attendees of the&#xD;
             HNS Oral Cancer Screening event who are willing to participate.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Subjects with a current diagnosis of oral cancer.&#xD;
&#xD;
          2. Subjects under the age of 18. It is extremely unusual for children to develop oral&#xD;
             cancer, therefore data from persons younger than 18 may add unexpected variables which&#xD;
             could affect data analysis.&#xD;
&#xD;
          3. Subjects who are unable or unwilling to give informed consent.&#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>Ann M. Gillenwater, MD, BA</last_name>
    <role>Principal Investigator</role>
    <affiliation>M.D. Anderson Cancer Center</affiliation>
  </overall_official>
  <removed_countries>
    <country>United States</country>
  </removed_countries>
  <link>
    <url>http://www.mdanderson.org</url>
    <description>University of Texas MD Anderson Cancer Center Website</description>
  </link>
  <verification_date>April 2017</verification_date>
  <study_first_submitted>September 23, 2014</study_first_submitted>
  <study_first_submitted_qc>September 25, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 29, 2014</study_first_posted>
  <last_update_submitted>April 25, 2017</last_update_submitted>
  <last_update_submitted_qc>April 25, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">April 27, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Oral cancer</keyword>
  <keyword>Pre-cancer</keyword>
  <keyword>Widefield Fluorescence Imaging</keyword>
  <keyword>VELScope</keyword>
  <keyword>Point Spectroscopy System</keyword>
  <keyword>Oral brush biopsy</keyword>
  <keyword>Questionnaire</keyword>
  <keyword>Survey</keyword>
  <keyword>Diagnostic aid</keyword>
  <keyword>Screening</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Mouth Neoplasms</mesh_term>
  </condition_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/NCT02251639
org study id: 2012-0887
secondary id: NCI-2014-02105
secondary id: RO1 910576
secondary id: 960113
nct id: NCT02251639
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
The goal of this clinical study is to find out if certain instruments/devices, such as wide
      field fluorescence imaging point spectroscopy and/or brush cytology, can help health care
      providers find mouth cancer more quickly than a standard oral clinical exam.
Study Procedures:

      Certain types of light may cause cells to give off a tiny amount of light (called
      fluorescence). Researchers have learned that cancer cells and normal cells reflect light and
      give off fluorescence differently. Researchers want to find out if different kinds of light
      can be used to discover areas of the mouth that may have abnormal or cancerous cells.

      If you agree to take part in this study, a researcher may use up to 3 types of imaging
      instruments to take pictures and readings of several areas in your mouth.

        -  VELScope is an FDA approved handheld camera device that takes images of the mouth with
           different colors of light. The VELScope shines blue light into the mouth, and pictures
           are taken using a camera that is attached to the device.

        -  Widefield Fluorescence Imaging uses a non-contact imaging device similar to the
           VELScope. It shines different colors of light and then takes pictures of the inside of
           the mouth using a digital camera.

        -  Point Spectroscopy System uses a probe (about the size of a tip of a pen) that is gently
           placed on several areas of the mouth. Different colors of light are directed through
           optic fibers to the lining of the mouth, and the probe collects the light that returns
           from the tissue and sends the information to a computer.

      Researchers will record whether the doctors find any areas within your mouth that may not
      appear completely normal. They will collect tissue samples of these abnormal areas using a
      brush biopsy. To perform an oral brush biopsy, the research will press a small brush against
      an area inside your mouth, and turn it 5-10 times. The areas that could be biopsied include
      your gums, tongue, the roof of your mouth, the bottom of your mouth, or the inside of your
      cheeks. Any cells collected from the inside of your mouth will be placed on slides to be
      studied by the study team.

      The samples being collected will only be used for this testing, and no leftover samples will
      be kept by the research staff.

      These procedures should take about 20 minutes total.

      This is an investigational study. The VELScope is an FDA approved device and is commercially
      available. Wide-field and point spectroscopy systems are not FDA approved and are only
      authorized for research. Up to 500 participants will take part in this multicenter study. Up
      to 250 will be enrolled at MD Anderson.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Performance of the POS, PS2 and VELscope as Diagnostic Aid for Oral Cancer
time frame: 1 day
description: Information obtained from the fluorescence and reflectance images, point spectroscopy, and oral cytology compared with clinical diagnosis to evaluate the performance of the diagnostic aids and assess any clinical benefit to assist in screening for oral cancer. ROC curve analysis used as primary method for evaluating the performance of the POS, PS2 and VELscope devices as compared to the white light standard clinical diagnosis.
arm group label: Oral Imaging and Cytology
arm group type: Experimental
description: Participant completes a short questionnaire regarding their awareness of oral cancer and risk factors. Oral cavity inspected using a standard white light headlamp. Oral cavity then examined with one or more of the widefield imaging devices, such as the VELscope and/or PS2 device. Exfoliative cells for cytology from an abnormal area (if present) and from a contralateral normal appearing area obtained using a brush.
intervention type: Behavioral
intervention name: Questionnaire
description: Participant completes a short questionnaire regarding their awareness of oral cancer and risk factors.
arm group label: Oral Imaging and Cytology
other name: Survey
intervention type: Device
intervention name: POS + PS2 + VELscope
description: Oral cavity examined with one or more of the widefield imaging devices, such as the VELscope and/or PS2 device.
arm group label: Oral Imaging and Cytology
intervention type: Procedure
intervention name: Oral Brush Biopsy
description: If abnormal areas found, a small brush is pressed against an area inside mouth, and turned 5-10 times. The areas that could be biopsied include gums, tongue, roof of mouth, bottom of mouth, or the inside of cheeks.
arm group label: Oral Imaging and Cytology
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Ann M. Gillenwater, MD, BA
role: Principal Investigator
affiliation: M.D. Anderson Cancer Center
country: United States
url: http://www.mdanderson.org
description: University of Texas MD Anderson Cancer Center Website
responsible party type: Sponsor
mesh term: Mouth Neoplasms