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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT02574442
Other study ID # BCCR - H15-01726
Secondary ID P01CA082710H15-0
Status Terminated
Phase
First received
Last updated
Start date September 1, 2019
Est. completion date June 1, 2020

Study information

Verified date March 2024
Source British Columbia Cancer Agency
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Terminated
Enrollment 60
Est. completion date June 1, 2020
Est. primary completion date December 31, 2019
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility 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


Intervention

Device:
In Vivo Confocal Microscopy Probe
Participants will have 2 areas on their cervical imaged by the confocal probe.

Locations

Country Name City State
Canada Vancouver General Hospital Vancouver British Columbia

Sponsors (2)

Lead Sponsor Collaborator
British Columbia Cancer Agency National Cancer Institute (NCI)

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
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