Clinical trial NCT03285841: 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
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Cervical Dysplasia
Vulvar Dysplasia
Precancerous Lesions
Vulvar Cancer
Cervical Cancer
Keywords: cervical cancer
vulvar cancer
optical coherence tomography
autofluorescence imaging
Lead sponsor: British Columbia Cancer Agency
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
First posted: 2017-09-18
Enrollment: 20
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: OTHER
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.

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.

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

Primary outcomes:
measure: Determine ease of use of OCT-AFI in imaging cervix or vulva lesions.
timeFrame: Total imaging session of cervix and canal or vulva should take no more than 5 minutes
Secondary outcomes:
measure: Correlate OCT-AFI images with histology images
timeFrame: 6 months
measure: Quantify OCT-AFI images by examining epithelial thickness
timeFrame: 6 months
measure: Locate basement membrane invasion and loss of normal endogenous fluorescence
timeFrame: 6 months
measure: Note extent of vasculature and its features
timeFrame: 6 months
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: Vancouver General Hospital Women's Clinic
state: British Columbia
Study officials:
affiliation: British Columbia Cancer Agency
name: Calum MacAulay, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
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: 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: 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.