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Cervical DysplasiaNCT03285841

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

An observational study of Cervical Dysplasia and Vulvar Dysplasia, run by British Columbia Cancer Agency at 1 site in Canada.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older, women only
What is being tested?
OCT-AFI
Type of treatment
Medical device
How many people
20 participants
Where
1 siteCanada
Study dates
25 Jul 2019to 30 Dec 2020
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • 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)

Who cannot join

  • breastfeeding

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • Vancouver General Hospital Women's Clinic

    Vancouver, British Columbia, V5Z 1M9

Other trials in Canada

About this study

Official title: 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).
Read the 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.

Being tested
OCT-AFI
Keywords
cervical cancer, vulvar cancer, optical coherence tomography, autofluorescence imaging
Medical subject headings
Uterine Cervical Dysplasia, Vulvar Neoplasms, Uterine Cervical Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • OCT-AFIDevice

    Also called Multimodal imaging

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

Study groups in NCT03285841
Study groupRoleWhat they receive
Cervical SitesImaging complete cervix from endocervical canal to transformation zone to ectocervix.
Receives: Device: OCT-AFI
Vulvar sitesImaging vulvar lesions
Receives: Device: OCT-AFI

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Total imaging session of cervix and canal or vulva should take no more than 5 minutes

Secondary outcomes (4)

  1. Correlate OCT-AFI images with histology images

    Correlate sub-epithelial structures seen in OCT-AFI with histology images

    Measured: 6 months

  2. Quantify OCT-AFI images by examining epithelial thickness

    Measure epithelial thickness along entire scanned image. Units of measure in millimeters.

    Measured: 6 months

  3. 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.

    Measured: 6 months

  4. Note extent of vasculature and its features

    Make notes regarding vasculature patterns seen in the OCT-AFI images.

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Sep 2017
  2. Study start25 Jul 2019
  3. Primary completion30 Jun 2020
  4. Study completion30 Dec 2020

Why it stopped: No funding

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Other
Enrolment
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03285841
Sponsor's protocol ID
BCCR-H17-02004
Status last verified
Mar 2024
First submitted
12 Sep 2017
Last updated
18 Mar 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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.

    PubMed 23625308

  • 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.

    PubMed 26504665

  • 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.

    PubMed 25401011

Questions about this trial

What is this clinical trial studying?

An observational study of Cervical Dysplasia and Vulvar Dysplasia, run by British Columbia Cancer Agency at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 18 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was stopped early (reason given: No funding). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Determine ease of use of OCT-AFI in imaging cervix or vulva lesions. (time frame: Total imaging session of cervix and canal or vulva should take no more than 5 minutes). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03285841, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2024.

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