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

Cervical Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03285841
• Other study ID #: BCCR-H17-02004
• Status: Terminated
• Start date: July 25, 2019
• Est. completion date: December 30, 2020

Study information

• Verified date: March 2024
• Source: British Columbia Cancer Agency
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 20
• Est. completion date: December 30, 2020
• Est. primary completion date: June 30, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cervical Cancer
• Cervical Dysplasia
• Precancerous Lesions
• Uterine Cervical Dysplasia
• Uterine Cervical Neoplasms
• Vulvar Cancer
• Vulvar Dysplasia
• Vulvar Neoplasms

Intervention

Device:
• OCT-AFI
Both groups will be imaged with the OCT-AFI device. Imaging will not influence standard of care biospies, treatment and procedures.

Locations

Country	Name	City	State
Canada	Vancouver General Hospital Women's Clinic	Vancouver	British Columbia

Sponsors (2)

Lead Sponsor	Collaborator
British Columbia Cancer Agency	Canadian Institutes of Health Research (CIHR)

Country where clinical trial is conducted

Canada, 

References & Publications (3)

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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Correlate OCT-AFI images with histology images	Correlate sub-epithelial structures seen in OCT-AFI with histology images	6 months
Secondary	Quantify OCT-AFI images by examining epithelial thickness	Measure epithelial thickness along entire scanned image. Units of measure in millimeters.	6 months
Secondary	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
Secondary	Note extent of vasculature and its features	Make notes regarding vasculature patterns seen in the OCT-AFI images.	6 months