Pilot Study In Vivo Confocal Microscopy Probe for Cervical Precancer

Sponsor

British Columbia Cancer Agency (Other)

Overall Status

Suspended

CT.gov ID

NCT02574442

Collaborator

National Cancer Institute (NCI) (NIH)

Enrollment

Location

Anticipated Duration (Months)

6.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Precancerous Condition Cervical Cancer	Device: In Vivo Confocal Microscopy Probe

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 Design

Study Type:

Observational

Anticipated Enrollment :

60 participants

Observational Model:

Case-Only

Time Perspective:

Prospective

Official Title:

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

Anticipated Study Start Date :

Sep 1, 2019

Anticipated Primary Completion Date :

Dec 1, 2019

Anticipated Study Completion Date :

Jun 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
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.

Arm

Intervention/Treatment

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.

Outcome Measures

Primary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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