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Pilot Study In Vivo Confocal Microscopy Probe for Cervical Precancer (Confocal)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02574442
Recruitment Status : Suspended (Funding has run out but we are trying to secure more funding.)
First Posted : October 12, 2015
Last Update Posted : July 4, 2019
National Cancer Institute (NCI)
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
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.

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Study Type : Observational
Estimated 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
Estimated Study Start Date : September 2019
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : June 2020

Resource links provided by the National Library of Medicine

Group/Cohort 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.

Primary Outcome Measures :
  1. Detection of pre-cancer abnormalities of the cervix by the confocal microscopy probe [ Time Frame: Probe measurements on participant's cervix should take no more than 10 minutes during the clinical visit ]

Biospecimen Retention:   Samples Without DNA
Cervical biopsies

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Be scheduled for colposcopy & biopsy at the Vancouver General Hospital Women's Clinic

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02574442

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Canada, British Columbia
Vancouver General Hospital
Vancouver, British Columbia, Canada, V5Z 1M9
Sponsors and Collaborators
British Columbia Cancer Agency
National Cancer Institute (NCI)
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Principal Investigator: Marette Lee, MD BC Cancer Agency, Gynecologic Oncology

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Responsible Party: British Columbia Cancer Agency Identifier: NCT02574442     History of Changes
Other Study ID Numbers: BCCR - H15-01726
P01CA082710 ( U.S. NIH Grant/Contract )
H15-01726 ( Other Identifier: UBC BCCA REB )
First Posted: October 12, 2015    Key Record Dates
Last Update Posted: July 4, 2019
Last Verified: July 2019
Keywords provided by British Columbia Cancer Agency:
cervical intraepithelial neoplasia grade 1
cervical intraepithelial neoplasia grade 2
cervical intraepithelial neoplasia grade 3
adenocarcinoma in situ
Additional relevant MeSH terms:
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Cervical Intraepithelial Neoplasia
Precancerous Conditions
Carcinoma in Situ
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type