Clinical trial · Observational
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): No funding
Summary
Brief summary (as posted)
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).
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cervical Cancer | Malignant Cervical Neoplasm | CURATED_EXACT | 0.92 |
| Cervical Dysplasia | Cervical Intraepithelial Neoplasia | ALIAS | 0.90 |
| Precancerous Lesions | — | UNRESOLVED | — |
| Vulvar Cancer | Malignant Vulvar Neoplasm | CURATED_EXACT | 0.92 |
| Vulvar Dysplasia | Vulvar Intraepithelial Neoplasia | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| OCT-AFI | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Cervical Sites
- description
- Imaging complete cervix from endocervical canal to transformation zone to ectocervix.
- interventionNames
- Device: OCT-AFI
- label
- Vulvar sites
- description
- Imaging vulvar lesions
- interventionNames
- Device: OCT-AFI
Primary outcomes (1)
- 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
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (3)
- BACKGROUNDLee 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
- BACKGROUNDPahlevaninezhad 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
- BACKGROUNDPahlevaninezhad 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