Clinical Trial: Pilot Study In Vivo Confocal Microscopy Probe for Cervical Precancer

Study Status: Suspended
Recruit Status: Suspended
Study Type: Observational

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

Brief Summary: 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.

Detailed Summary:

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.

Sponsor: British Columbia Cancer Agency

Current Primary Outcome: 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 ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: British Columbia Cancer Agency

Dates:
Date Received: September 1, 2015
Date Started: September 2017
Date Completion: December 2018
Last Updated: January 30, 2017
Last Verified: January 2017