NCT02574442

Pilot Study In Vivo Confocal Microscopy Probe for Cervical Precancer

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

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 60 (actual)
• Sponsor: British Columbia Cancer Agency · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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 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.

Conditions

• Precancerous Condition
• Cervical Cancer

Interventions

Type	Name	Description
DEVICE	In Vivo Confocal Microscopy Probe	Participants will have 2 areas on their cervical imaged by the confocal probe.

Timeline

• Start date: 2019-09-01
• Primary completion: 2019-12-31
• Completion: 2020-06-01
• First posted: 2015-10-12
• Last updated: 2024-03-18

Locations

1 site across 1 country: Canada