Clinical trial NCT02574442: Pilot Study In Vivo Confocal Microscopy Probe for Cervical Precancer
Official title: Pilot Study of the Hand-held In Vivo Confocal Microscopy Probe for Detection of Cervical Intraepithelial Neoplasia
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Precancerous Condition
Cervical Cancer
Keywords: cervical intraepithelial neoplasia grade 1
cervical intraepithelial neoplasia grade 2
cervical intraepithelial neoplasia grade 3
adenocarcinoma in situ
Lead sponsor: British Columbia Cancer Agency
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2015-10-12
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Be scheduled for colposcopy \& biopsy at the Vancouver General Hospital Women's Clinic

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.

Eligibility criteria: 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

Primary outcomes:
measure: Detection of pre-cancer abnormalities of the cervix by the confocal microscopy probe
timeFrame: Probe measurements on participant's cervix should take no more than 10 minutes during the clinical visit
Secondary outcomes:
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: Vancouver General Hospital
state: British Columbia
Study officials:
affiliation: BC Cancer Agency, Gynecologic Oncology
name: Marette Lee, MD
role: PRINCIPAL_INVESTIGATOR
References: