Pilot Study In Vivo Confocal Microscopy Probe for Cervical Precancer

Cervical Cancer Clinical Trial

— Confocal  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02574442
• Other study ID #: BCCR - H15-01726
• Secondary ID: P01CA082710H15-0
• Status: Terminated
• 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
• 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

Related Conditions & MeSH terms

• Cervical Cancer
• Precancerous Condition
• Precancerous Conditions
• Uterine Cervical Dysplasia

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