Pilot Study In Vivo Confocal Microscopy Probe for Cervical Precancer (Confocal)
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|ClinicalTrials.gov Identifier: NCT02574442|
Recruitment Status : Suspended (Funding has run out but we are trying to secure more funding.)
First Posted : October 12, 2015
Last Update Posted : July 4, 2019
|Condition or disease||Intervention/treatment|
|Precancerous Condition Cervical Cancer||Device: In Vivo Confocal Microscopy Probe|
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|
|Estimated Enrollment :||60 participants|
|Official Title:||Pilot Study of the Hand-held In Vivo Confocal Microscopy Probe for Detection of Cervical Intraepithelial Neoplasia|
|Estimated Study Start Date :||September 2019|
|Estimated Primary Completion Date :||December 2019|
|Estimated Study Completion Date :||June 2020|
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.
- 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 ]
Biospecimen Retention: Samples Without DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02574442
|Canada, British Columbia|
|Vancouver General Hospital|
|Vancouver, British Columbia, Canada, V5Z 1M9|
|Principal Investigator:||Marette Lee, MD||BC Cancer Agency, Gynecologic Oncology|