Pilot Study In Vivo Confocal Microscopy Probe for Cervical Precancer (Confocal)
Pilot Study of the Hand-held In Vivo Confocal Microscopy Probe for Detection of Cervical Intraepithelial Neoplasia
Study Overview
Status
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
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
British Columbia
-
Vancouver, British Columbia, Canada, V5Z 1M9
- Vancouver General Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
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
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
|
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
Sponsor
Collaborators
Investigators
- Principal Investigator: Marette Lee, MD, BC Cancer Agency, Gynecologic Oncology
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
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.