OCT-AF Imaging of Pre-cancers of Vulva and Cervix

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Brief Title

OCT-AF Imaging of Pre-cancers of Vulva and Cervix

Official Title

Co-registered Multimodal Optical Imaging for the Early Detection and Management of Cancers of the Vulva and Cervix

Brief Summary

      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).
    

Detailed Description

      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.
    


Study Type

Observational


Primary Outcome

Determine ease of use of OCT-AFI in imaging cervix or vulva lesions.

Secondary Outcome

 Correlate OCT-AFI images with histology images

Condition

Cervical Dysplasia

Intervention

OCT-AFI

Study Arms / Comparison Groups

 Cervical Sites
Description:  Imaging complete cervix from endocervical canal to transformation zone to ectocervix.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Device

Estimated Enrollment

20

Start Date

July 25, 2019

Completion Date

December 30, 2020

Primary Completion Date

June 30, 2020

Eligibility Criteria

        Inclusion Criteria:

          -  indicates understanding of study

          -  provides informed consent to participate

          -  18 years or older

          -  not pregnant and have negative urine pregnancy test

          -  be scheduled for initial visit colposcopy for cervix or vulva or LEEP (loop
             electrosurgical excision procedure) for treatment of abnormalities on cervix at the
             Women's Clinic at Vancouver General Hospital (VGH)

        Exclusion Criteria:

          -  breastfeeding
      

Gender

Female

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Calum MacAulay, Ph.D., 604-675-8093, [email protected]

Location Countries

Canada

Location Countries

Canada

Administrative Informations


NCT ID

NCT03285841

Organization ID

BCCR-H17-02004


Responsible Party

Sponsor

Study Sponsor

British Columbia Cancer Agency

Collaborators

 Canadian Institutes of Health Research (CIHR)

Study Sponsor

Calum MacAulay, Ph.D., Principal Investigator, British Columbia Cancer Agency


Verification Date

January 2020