Pilot Study In Vivo Confocal Microscopy Probe for Cervical Precancer

Terminated

• Conditions: Cervical Cancer; Precancerous Condition
• Interventions: Device: In Vivo Confocal Microscopy Probe

• Registration Number: NCT02574442
• Lead Sponsor: British Columbia Cancer Agency

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 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 Timeline

• Study First Submitted: 2015-09-01
• Study First Submitted QC: 2015-10-09
• Study First Posted: 2015-10-12
• Study Start: 2019-09-01
• Primary Completion: 2019-12-31
• Study Completion: 2020-06-01
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-15
• Last Update Posted: 2024-03-18

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 60

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Initial Colposcopy Visit	In Vivo Confocal Microscopy Probe	Women with a scheduled colposcopy and biopsy appointment at the Women's Clinic at Vancouver General Hospital

Primary Outcome Measures

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

Trial Locations

Locations (1)

Vancouver General Hospital; 🇨🇦 Vancouver, British Columbia, Canada