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

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

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).

Study Overview

• Status: Terminated
• Conditions: Cervical Cancer; Vulvar Cancer; Precancerous Lesions; Cervical Dysplasia; Vulvar Dysplasia
• Intervention / Treatment: 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
• Enrollment (Actual): 20

Contacts and Locations

Study Locations

• Canada
  • British Columbia
    • Vancouver, British Columbia, Canada, V5Z 1M9
      • Vancouver General Hospital Women's Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

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 Names: 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 Names: Multimodal imaging

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Determine ease of use of OCT-AFI in imaging cervix or vulva lesions.	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.	Total imaging session of cervix and canal or vulva should take no more than 5 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Correlate OCT-AFI images with histology images	Correlate sub-epithelial structures seen in OCT-AFI with histology images	6 months
Quantify OCT-AFI images by examining epithelial thickness	Measure epithelial thickness along entire scanned image. Units of measure in millimeters.	6 months
Locate basement membrane invasion and loss of normal endogenous fluorescence	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.	6 months
Note extent of vasculature and its features	Make notes regarding vasculature patterns seen in the OCT-AFI images.	6 months

Collaborators and Investigators

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

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): July 25, 2019
• Primary Completion (Actual): June 30, 2020
• Study Completion (Actual): December 30, 2020

Study Registration Dates

• First Submitted: September 12, 2017
• First Submitted That Met QC Criteria: September 13, 2017
• First Posted (Actual): September 18, 2017

Study Record Updates

• Last Update Posted (Actual): March 18, 2024
• Last Update Submitted That Met QC Criteria: March 15, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: optical coherence tomography; cervical cancer; vulvar cancer; autofluorescence imaging
• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Uterine Neoplasms; Genital Neoplasms, Female; Uterine Cervical Diseases; Uterine Diseases; Precancerous Conditions; Vulvar Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Genital Diseases, Female; Uterine Cervical Neoplasms; Vulvar Neoplasms; Uterine Cervical Dysplasia
• Other Study ID Numbers: BCCR-H17-02004

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No