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

NCT03285841 | Terminated

• 1 other identifier: BCCR-H17-02004
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

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. 1.feasibility of the technology in imaging vulva and its capability in detecting vulvar intraepithelial neoplasias
2. 2.feasibility in imaging cervix from endocervical canal to transformation zone to ectocervix
3. 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).

Conditions

Cervical Dysplasia; Vulvar Dysplasia; Precancerous Lesions; Vulvar Cancer; Cervical Cancer

Keywords

cervical cancer; vulvar cancer; optical coherence tomography; autofluorescence imaging

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Correlate OCT-AFI images with histology images

  6 months

• Quantify OCT-AFI images by examining epithelial thickness

  6 months

• Locate basement membrane invasion and loss of normal endogenous fluorescence

  6 months

• Note extent of vasculature and its features

  6 months

Study Arms (2)

Cervical Sites

Imaging complete cervix from endocervical canal to transformation zone to ectocervix.

Device: OCT-AFI

Vulvar sites

Imaging vulvar lesions

Device: OCT-AFI

Interventions

OCT-AFI DEVICE

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

Also known as: Multimodal imaging

Cervical Sites; Vulvar sites

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• indicates understanding of study
• provides informed consent to participate
• 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)

You may not qualify if:

• breastfeeding

Sponsors & Collaborators

• British Columbia Cancer Agency: lead
• Canadian Institutes of Health Research (CIHR): collaborator

Study Sites (1)

Vancouver General Hospital Women's Clinic

Vancouver, British Columbia, V5Z 1M9, Canada

Location

Related 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.

  PMID: 23625308 BACKGROUND

• 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.

  PMID: 26504665 BACKGROUND

• 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.

  PMID: 25401011 BACKGROUND

MeSH Terms

Conditions

Uterine Cervical Dysplasia; Vulvar Neoplasms; Uterine Cervical Neoplasms

Interventions

Multimodal Imaging

Condition Hierarchy (Ancestors)

Precancerous Conditions; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Vulvar Diseases; Uterine Neoplasms

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Calum MacAulay, Ph.D.

  British Columbia Cancer Agency

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 12, 2017
• First Posted: September 18, 2017
• Study Start: July 25, 2019
• Primary Completion: June 30, 2020
• Study Completion: December 30, 2020
• Last Updated: March 18, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)