ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 23 of 148 for:    vulvar cancer

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03285841
Recruitment Status : Not yet recruiting
First Posted : September 18, 2017
Last Update Posted : February 6, 2018
Sponsor:
Collaborator:
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
British Columbia Cancer Agency

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).

Condition or disease Intervention/treatment
Cervical Dysplasia Vulvar Dysplasia Precancerous Lesions Vulvar Cancer Cervical Cancer Device: OCT-AFI

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
Estimated Enrollment : 20 participants
Observational Model: Other
Time Perspective: Other
Official Title: Co-registered Multimodal Optical Imaging for the Early Detection and Management of Cancers of the Vulva and Cervix
Estimated Study Start Date : May 30, 2018
Estimated Primary Completion Date : January 1, 2019
Estimated Study Completion Date : December 31, 2019


Group/Cohort Intervention/treatment
Cervical Sites
Imaging complete cervix from endocervical canal to transformation zone to ectocervix.
Device: OCT-AFI
Both groups will be imaged with the OCT-AFI device. Imaging will not influence standard of care biospies, treatment and procedures.
Other Name: Multimodal imaging

Vulvar sites
Imaging vulvar lesions
Device: OCT-AFI
Both groups will be imaged with the OCT-AFI device. Imaging will not influence standard of care biospies, treatment and procedures.
Other Name: Multimodal imaging




Primary Outcome Measures :
  1. 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 ]
    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.


Secondary Outcome Measures :
  1. Correlate OCT-AFI images with histology images [ Time Frame: 6 months ]
    Correlate sub-epithelial structures seen in OCT-AFI with histology images

  2. Quantify OCT-AFI images by examining epithelial thickness [ Time Frame: 6 months ]
    Measure epithelial thickness along entire scanned image. Units of measure in millimeters.

  3. Locate basement membrane invasion and loss of normal endogenous fluorescence [ Time Frame: 6 months ]
    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.

  4. Note extent of vasculature and its features [ Time Frame: 6 months ]
    Make notes regarding vasculature patterns seen in the OCT-AFI images.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Participants will be recruited from VGH Women's Clinic. They will have a scheduled appointment for an initial visit colposcopy for cervix or vulva (that is, a biopsy will be done) or they will have a scheduled LEEP appointment.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03285841


Contacts
Contact: Sylvia Lam 604-675-8093 sflam@bccrc.ca

Sponsors and Collaborators
British Columbia Cancer Agency
Canadian Institutes of Health Research (CIHR)
Investigators
Principal Investigator: Calum MacAulay, Ph.D. British Columbia Cancer Agency

Publications:
Responsible Party: British Columbia Cancer Agency
ClinicalTrials.gov Identifier: NCT03285841     History of Changes
Other Study ID Numbers: BCCR-H17-02004
First Posted: September 18, 2017    Key Record Dates
Last Update Posted: February 6, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by British Columbia Cancer Agency:
cervical cancer
vulvar cancer
optical coherence tomography
autofluorescence imaging

Additional relevant MeSH terms:
Uterine Cervical Neoplasms
Vulvar Neoplasms
Cervical Intraepithelial Neoplasia
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Vulvar Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Uterine Cervical Dysplasia
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female
Precancerous Conditions
Carcinoma in Situ
Carcinoma