<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/NCT03285841</url>
  </required_header>
  <id_info>
    <org_study_id>BCCR-H17-02004</org_study_id>
    <nct_id>NCT03285841</nct_id>
  </id_info>
  <brief_title>OCT-AF Imaging of Pre-cancers of Vulva and Cervix</brief_title>
  <official_title>Co-registered Multimodal Optical Imaging for the Early Detection and Management of Cancers of the Vulva and Cervix</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>British Columbia Cancer Agency</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Canadian Institutes of Health Research (CIHR)</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>British Columbia Cancer Agency</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>
      The multimodal imaging technology, OCT-AFI, will be used to image sites on the cervix, the&#xD;
      endocervical canal and vulva. The imaging probe is small enough, it can be inserted into the&#xD;
      endocervical canal for imaging. The probe can also be placed in a conformable holder that can&#xD;
      be shaped to conform the the folds of the vulva for vulvar imaging. The resultant images will&#xD;
      be compared to histology images.&#xD;
&#xD;
      The objectives are to determine&#xD;
&#xD;
        1. feasibility of the technology in imaging vulva and its capability in detecting vulvar&#xD;
           intraepithelial neoplasias&#xD;
&#xD;
        2. feasibility in imaging cervix from endocervical canal to transformation zone to&#xD;
           ectocervix&#xD;
&#xD;
        3. if combined OCT with AFI increases the sensitivity of detecting high grade lesions in&#xD;
           the cervix compared to just AFI alone (previous work was AFI alone).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The multimodal optical imaging technology, OCT-AFI, has demonstrated the ability to image the&#xD;
      small peripheral airways of the lung, allowing for high resolution of structural and&#xD;
      functional details of airway tissue and the vasculature. Through the OCT (optical coherence&#xD;
      tomography) component, the bronchial epithelium can be visualized and its thickness&#xD;
      quantifiable. Micro invasion of the basement membrane can be seen in the acquired images. The&#xD;
      AFI (autofluorescence imaging) component showed the vascular network, areas of pulmonary&#xD;
      fibrosis and areas with loss of endogenous fluorescence beside pulmonary nodules.&#xD;
&#xD;
      The investigators anticipate OCT-AFI to be able to see subsurface structures in the cervix&#xD;
      and vulva as well. Through previous work, the investigators found AFI to be sensitive to&#xD;
      detecting high grade cervical lesions but the technology was confounded by normal subsurface&#xD;
      tissue structures. By combining OCT with AFI, the investigators anticipate a higher&#xD;
      sensitivity to detecting high grade lesions on the cervix than with just AFI. The OCT-AFI&#xD;
      imaging probe is also small enough to fit into the endocervical canal and will allow for&#xD;
      imaging of neoplasias that originate in the canal. These abnormalities are on the rise.&#xD;
      Vulvar neoplasias are also on the rise and visually difficult to identify and determine&#xD;
      surgical margins. OCT-AFI may help clinicians locate and determine the extent of vulvar&#xD;
      lesions.&#xD;
&#xD;
      The objectives are to determine&#xD;
&#xD;
        1. feasibility of the technology in imaging vulva and its capability in detecting carcinoma&#xD;
           and vulvar intraepithelial neoplasias&#xD;
&#xD;
        2. feasibility in imaging complete cervix from endocervical canal to transformation zone to&#xD;
           ectocervix&#xD;
&#xD;
        3. if combined OCT with AFI increases the sensitivity of detecting high grade lesions in&#xD;
           the cervix compared to just AFI alone (previous work was AFI alone).&#xD;
&#xD;
      This study will image 10 subjects for endocervical canal and ectocervix sites. Another 10&#xD;
      subjects will be imaged for vulvar sites. Imaging will not affect where standard of care&#xD;
      biopsies will be taken from. Imaging results will be correlated with histology.&#xD;
&#xD;
      No statistical analysis will be performed. This feasibility study will look at the quality&#xD;
      and utility of the acquired image sets. If possible, the investigators will quantify the&#xD;
      images in terms of epithelium thickness, basement membrane location, presence of vasculature&#xD;
      and sub-epithelial structures.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">July 25, 2019</start_date>
  <completion_date type="Anticipated">December 30, 2020</completion_date>
  <primary_completion_date type="Anticipated">June 30, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Other</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Determine ease of use of OCT-AFI in imaging cervix or vulva lesions.</measure>
    <time_frame>Total imaging session of cervix and canal or vulva should take no more than 5 minutes</time_frame>
    <description>The ability to image complete cervix including endocervical canal or vulvar lesions in one continuous imaging run will indicate the device is feasible for use in the clinical setting for cervix and vulva. Note whether a complete image scan was collected or not after each imaging session.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Correlate OCT-AFI images with histology images</measure>
    <time_frame>6 months</time_frame>
    <description>Correlate sub-epithelial structures seen in OCT-AFI with histology images</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quantify OCT-AFI images by examining epithelial thickness</measure>
    <time_frame>6 months</time_frame>
    <description>Measure epithelial thickness along entire scanned image. Units of measure in millimeters.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Locate basement membrane invasion and loss of normal endogenous fluorescence</measure>
    <time_frame>6 months</time_frame>
    <description>Locate basement membrane in OCT-AFI images and note presence or absence of invasion. Note presence or absence of fluorescence in epithelial layer in images.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Note extent of vasculature and its features</measure>
    <time_frame>6 months</time_frame>
    <description>Make notes regarding vasculature patterns seen in the OCT-AFI images.</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">20</enrollment>
  <condition>Cervical Dysplasia</condition>
  <condition>Vulvar Dysplasia</condition>
  <condition>Precancerous Lesions</condition>
  <condition>Vulvar Cancer</condition>
  <condition>Cervical Cancer</condition>
  <arm_group>
    <arm_group_label>Cervical Sites</arm_group_label>
    <description>Imaging complete cervix from endocervical canal to transformation zone to ectocervix.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Vulvar sites</arm_group_label>
    <description>Imaging vulvar lesions</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>OCT-AFI</intervention_name>
    <description>Both groups will be imaged with the OCT-AFI device. Imaging will not influence standard of care biospies, treatment and procedures.</description>
    <arm_group_label>Cervical Sites</arm_group_label>
    <arm_group_label>Vulvar sites</arm_group_label>
    <other_name>Multimodal imaging</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Participants will be recruited from VGH Women's Clinic. They will have a scheduled&#xD;
        appointment for an initial visit colposcopy for cervix or vulva (that is, a biopsy will be&#xD;
        done) or they will have a scheduled LEEP appointment.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  indicates understanding of study&#xD;
&#xD;
          -  provides informed consent to participate&#xD;
&#xD;
          -  18 years or older&#xD;
&#xD;
          -  not pregnant and have negative urine pregnancy test&#xD;
&#xD;
          -  be scheduled for initial visit colposcopy for cervix or vulva or LEEP (loop&#xD;
             electrosurgical excision procedure) for treatment of abnormalities on cervix at the&#xD;
             Women's Clinic at Vancouver General Hospital (VGH)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  breastfeeding&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Calum MacAulay, Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>British Columbia Cancer Agency</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Sylvia Lam</last_name>
    <phone>604-675-8093</phone>
    <email>sflam@bccrc.ca</email>
  </overall_contact>
  <location>
    <facility>
      <name>Vancouver General Hospital Women's Clinic</name>
      <address>
        <city>Vancouver</city>
        <state>British Columbia</state>
        <zip>V5Z 1M9</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Sylvia Lam</last_name>
    </contact>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <reference>
    <citation>Lee AM, Ohtani K, Macaulay C, McWilliams A, Shaipanich T, Yang VX, Lam S, Lane P. In vivo lung microvasculature visualized in three dimensions using fiber-optic color Doppler optical coherence tomography. J Biomed Opt. 2013 May;18(5):50501. doi: 10.1117/1.JBO.18.5.050501.</citation>
    <PMID>23625308</PMID>
  </reference>
  <reference>
    <citation>Pahlevaninezhad H, Lee AM, Ritchie A, Shaipanich T, Zhang W, Ionescu DN, Hohert G, MacAulay C, Lam S, Lane P. Endoscopic Doppler optical coherence tomography and autofluorescence imaging of peripheral pulmonary nodules and vasculature. Biomed Opt Express. 2015 Sep 30;6(10):4191-9. doi: 10.1364/BOE.6.004191. eCollection 2015 Oct 1.</citation>
    <PMID>26504665</PMID>
  </reference>
  <reference>
    <citation>Pahlevaninezhad H, Lee AM, Shaipanich T, Raizada R, Cahill L, Hohert G, Yang VX, Lam S, MacAulay C, Lane P. A high-efficiency fiber-based imaging system for co-registered autofluorescence and optical coherence tomography. Biomed Opt Express. 2014 Aug 6;5(9):2978-87. doi: 10.1364/BOE.5.002978. eCollection 2014 Sep 1.</citation>
    <PMID>25401011</PMID>
  </reference>
  <verification_date>January 2020</verification_date>
  <study_first_submitted>September 12, 2017</study_first_submitted>
  <study_first_submitted_qc>September 13, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 18, 2017</study_first_posted>
  <last_update_submitted>January 21, 2020</last_update_submitted>
  <last_update_submitted_qc>January 21, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">January 22, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>cervical cancer</keyword>
  <keyword>vulvar cancer</keyword>
  <keyword>optical coherence tomography</keyword>
  <keyword>autofluorescence imaging</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Uterine Cervical Neoplasms</mesh_term>
    <mesh_term>Vulvar Neoplasms</mesh_term>
    <mesh_term>Uterine Cervical Dysplasia</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT03285841
org study id: BCCR-H17-02004
nct id: NCT03285841
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The multimodal imaging technology, OCT-AFI, will be used to image sites on the cervix, the
      endocervical canal and vulva. The imaging probe is small enough, it can be inserted into the
      endocervical canal for imaging. The probe can also be placed in a conformable holder that can
      be shaped to conform the the folds of the vulva for vulvar imaging. The resultant images will
      be compared to histology images.

      The objectives are to determine

        1. feasibility of the technology in imaging vulva and its capability in detecting vulvar
           intraepithelial neoplasias

        2. feasibility in imaging cervix from endocervical canal to transformation zone to
           ectocervix

        3. if combined OCT with AFI increases the sensitivity of detecting high grade lesions in
           the cervix compared to just AFI alone (previous work was AFI alone).
The multimodal optical imaging technology, OCT-AFI, has demonstrated the ability to image the
      small peripheral airways of the lung, allowing for high resolution of structural and
      functional details of airway tissue and the vasculature. Through the OCT (optical coherence
      tomography) component, the bronchial epithelium can be visualized and its thickness
      quantifiable. Micro invasion of the basement membrane can be seen in the acquired images. The
      AFI (autofluorescence imaging) component showed the vascular network, areas of pulmonary
      fibrosis and areas with loss of endogenous fluorescence beside pulmonary nodules.

      The investigators anticipate OCT-AFI to be able to see subsurface structures in the cervix
      and vulva as well. Through previous work, the investigators found AFI to be sensitive to
      detecting high grade cervical lesions but the technology was confounded by normal subsurface
      tissue structures. By combining OCT with AFI, the investigators anticipate a higher
      sensitivity to detecting high grade lesions on the cervix than with just AFI. The OCT-AFI
      imaging probe is also small enough to fit into the endocervical canal and will allow for
      imaging of neoplasias that originate in the canal. These abnormalities are on the rise.
      Vulvar neoplasias are also on the rise and visually difficult to identify and determine
      surgical margins. OCT-AFI may help clinicians locate and determine the extent of vulvar
      lesions.

      The objectives are to determine

        1. feasibility of the technology in imaging vulva and its capability in detecting carcinoma
           and vulvar intraepithelial neoplasias

        2. feasibility in imaging complete cervix from endocervical canal to transformation zone to
           ectocervix

        3. if combined OCT with AFI increases the sensitivity of detecting high grade lesions in
           the cervix compared to just AFI alone (previous work was AFI alone).

      This study will image 10 subjects for endocervical canal and ectocervix sites. Another 10
      subjects will be imaged for vulvar sites. Imaging will not affect where standard of care
      biopsies will be taken from. Imaging results will be correlated with histology.

      No statistical analysis will be performed. This feasibility study will look at the quality
      and utility of the acquired image sets. If possible, the investigators will quantify the
      images in terms of epithelium thickness, basement membrane location, presence of vasculature
      and sub-epithelial structures.
observational model: Other
time perspective: Other
measure: Determine ease of use of OCT-AFI in imaging cervix or vulva lesions.
time frame: Total imaging session of cervix and canal or vulva should take no more than 5 minutes
description: The ability to image complete cervix including endocervical canal or vulvar lesions in one continuous imaging run will indicate the device is feasible for use in the clinical setting for cervix and vulva. Note whether a complete image scan was collected or not after each imaging session.
measure: Correlate OCT-AFI images with histology images
time frame: 6 months
description: Correlate sub-epithelial structures seen in OCT-AFI with histology images
measure: Quantify OCT-AFI images by examining epithelial thickness
time frame: 6 months
description: Measure epithelial thickness along entire scanned image. Units of measure in millimeters.
measure: Locate basement membrane invasion and loss of normal endogenous fluorescence
time frame: 6 months
description: Locate basement membrane in OCT-AFI images and note presence or absence of invasion. Note presence or absence of fluorescence in epithelial layer in images.
measure: Note extent of vasculature and its features
time frame: 6 months
description: Make notes regarding vasculature patterns seen in the OCT-AFI images.
arm group label: Cervical Sites
description: Imaging complete cervix from endocervical canal to transformation zone to ectocervix.
arm group label: Vulvar sites
description: Imaging vulvar lesions
intervention type: Device
intervention name: OCT-AFI
description: Both groups will be imaged with the OCT-AFI device. Imaging will not influence standard of care biospies, treatment and procedures.
arm group label: Cervical Sites
arm group label: Vulvar sites
other name: Multimodal imaging
study pop: 
sampling method: Probability Sample
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Calum MacAulay, Ph.D.
role: Principal Investigator
affiliation: British Columbia Cancer Agency
last name: Sylvia Lam
phone: 604-675-8093
email: sflam@bccrc.ca
facility: 
status: Recruiting
contact: 
country: Canada
citation: Lee AM, Ohtani K, Macaulay C, McWilliams A, Shaipanich T, Yang VX, Lam S, Lane P. In vivo lung microvasculature visualized in three dimensions using fiber-optic color Doppler optical coherence tomography. J Biomed Opt. 2013 May;18(5):50501. doi: 10.1117/1.JBO.18.5.050501.
PMID: 23625308
citation: Pahlevaninezhad H, Lee AM, Ritchie A, Shaipanich T, Zhang W, Ionescu DN, Hohert G, MacAulay C, Lam S, Lane P. Endoscopic Doppler optical coherence tomography and autofluorescence imaging of peripheral pulmonary nodules and vasculature. Biomed Opt Express. 2015 Sep 30;6(10):4191-9. doi: 10.1364/BOE.6.004191. eCollection 2015 Oct 1.
PMID: 26504665
citation: Pahlevaninezhad H, Lee AM, Shaipanich T, Raizada R, Cahill L, Hohert G, Yang VX, Lam S, MacAulay C, Lane P. A high-efficiency fiber-based imaging system for co-registered autofluorescence and optical coherence tomography. Biomed Opt Express. 2014 Aug 6;5(9):2978-87. doi: 10.1364/BOE.5.002978. eCollection 2014 Sep 1.
PMID: 25401011
responsible party type: Sponsor
mesh term: Uterine Cervical Neoplasms
mesh term: Vulvar Neoplasms
mesh term: Uterine Cervical Dysplasia
sharing ipd: No