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

NCT03285841 · Status: TERMINATED · Type: OBSERVATIONAL · Enrollment: 20

Last updated 2024-03-18

No results posted yet for this study

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).

Conditions

  • Cervical Dysplasia
  • Vulvar Dysplasia
  • Precancerous Lesions
  • Vulvar Cancer
  • Cervical Cancer

Interventions

DEVICE

OCT-AFI

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

Sponsors & Collaborators

  • Canadian Institutes of Health Research (CIHR)

    collaborator OTHER_GOV

  • British Columbia Cancer Agency

    lead OTHER

Principal Investigators

  • Calum MacAulay, Ph.D. · British Columbia Cancer Agency

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-07-25
Primary Completion
2020-06-30
Completion
2020-12-30

Countries

  • Canada

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03285841 on ClinicalTrials.gov