Pilot Study In Vivo Confocal Microscopy Probe for Cervical Precancer (Confocal)

March 15, 2024 updated by: British Columbia Cancer Agency

Pilot Study of the Hand-held In Vivo Confocal Microscopy Probe for Detection of Cervical Intraepithelial Neoplasia

The goal of this proposal is to determine whether a hand-held confocal microscopy probe may perform better than standard methods in detecting cancer or pre-cancerous abnormalities of the cervix. The confocal probe will provide invivo histopathology-like images of cell morphology and three-dimensional tissue architecture non-invasively in real time.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

All subjects will undergo standard management (colposcopy) for their cervical lesion as scheduled. For cervical sites suspicious of dysplasia, acriflavine hydrochloride 0.05% solution will be applied topically, then rinsed with saline prior to in vivo confocal imaging with the hand-held probe. Following that, a biopsy of the suspicious site will be performed irrespective of the confocal microscopy finding. A biopsy of the normal site will be taken for research purposes. The confocal probe imaging will not alter where and how the biopsies will be taken (no change to size of biopsy or location on cervix).

The procedure will add approximately 15 minutes to the duration of the standard outpatient procedure. During each examination, the anatomical location of all tissue areas in question will be recorded using the clock-position nomenclature system. Some normal areas will be also localized and recorded as control. Digital images will be recorded in the computer.

Study Type

Observational

Enrollment (Actual)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z 1M9
        • Vancouver General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Be scheduled for colposcopy & biopsy at the Vancouver General Hospital Women's Clinic

Description

Inclusion Criteria:

  • indicate understanding of the study
  • provide informed consent to participate
  • 18 years old or older
  • not pregnant and have negative urine pregnancy test
  • be schedule for colposcopy & biopsy at the Vancouver General Hospital Women's Clinic

Exclusion Criteria:

  • they are breast-feeding
  • they had an operation to remove their cervix

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Initial Colposcopy Visit
Women with a scheduled colposcopy and biopsy appointment at the Women's Clinic at Vancouver General Hospital
Device: In Vivo Confocal Microscopy Probe
Participants will have 2 areas on their cervical imaged by the confocal probe.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Detection of pre-cancer abnormalities of the cervix by the confocal microscopy probe
Time Frame: Probe measurements on participant's cervix should take no more than 10 minutes during the clinical visit
Probe measurements on participant's cervix should take no more than 10 minutes during the clinical visit

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

British Columbia Cancer Agency

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Marette Lee, MD, BC Cancer Agency, Gynecologic Oncology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2019

Primary Completion (Actual)

December 31, 2019

Study Completion (Actual)

June 1, 2020

Study Registration Dates

First Submitted

September 1, 2015

First Submitted That Met QC Criteria

October 9, 2015

First Posted (Estimated)

October 12, 2015

Study Record Updates

Last Update Posted (Actual)

March 18, 2024

Last Update Submitted That Met QC Criteria

March 15, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BCCR - H15-01726
  • P01CA082710 (U.S. NIH Grant/Contract)
  • H15-01726 (Other Identifier: UBC BCCA REB)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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