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

British Columbia Cancer Agency

Status

Terminated

Conditions

Vulvar Cancer

Precancerous Lesions

Vulvar Dysplasia

Cervical Dysplasia

Cervical Cancer

Treatments

Device: OCT-AFI

Study type

Observational

Funder types

Other

Identifiers

NCT03285841

BCCR-H17-02004

Details and patient eligibility

About

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

feasibility of the technology in imaging vulva and its capability in detecting vulvar intraepithelial neoplasias
feasibility in imaging cervix from endocervical canal to transformation zone to ectocervix
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).

Full 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

feasibility of the technology in imaging vulva and its capability in detecting carcinoma and vulvar intraepithelial neoplasias
feasibility in imaging complete cervix from endocervical canal to transformation zone to ectocervix
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.

Enrollment

20 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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