Reflectance Confocal Imaging in Cervical Cancer Patients
NCT ID: NCT00505726
Last Updated: 2012-08-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
39 participants
OBSERVATIONAL
2001-11-30
2007-09-30
Brief Summary
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Primary Objectives:
1. To identify potential clinical advantages for a noninvasive method of diagnosing dysplasia and neoplasia in the cervix using reflectance confocal microscopy.
2. To obtain real time reflected light images in vivo of sites in the human cervix.
3. To access the effects of acetic acid as a contrast agent for in vivo reflectance confocal imaging.
4. Evaluate the depth of penetration for the fiber optic confocal device and analyze the diagnostic value of images taken from different depths.
5. Determine the sensitivity and specificity of this device for the diagnosis of CIN.
Detailed Description
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Microscopic images will be taken during the routine colposcopy in the outpatient clinic. A disinfected probe will be inserted into the vagina and placed against the cervix. . The probe sends out laser light and detects reflected light from the tissue. Images of cervical tissue will be formed and displayed on a computer monitor. 1-3 regions of the cervix will be imaged (2 abnormal and one normal), and each will take about 1-2 minutes.
Each imaged site will be biopsied. The biopsies will be analyzed by the research pathologist. The results will be available to participants in the event that care needs to be given. Total participation in this study will be only a few minutes.
This is an investigational study. About 72 women will take part in this study. About 18 will be enrolled at M. D. Anderson.
Conditions
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Keywords
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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Confocal Microscopy
Reflectance Confocal Imaging
Microscopic images taken during routine colposcopy where disinfected probe inserted into vagina and placed against cervix, 1-3 regions imaged (2 abnormal and one normal), and each taking about 1-2 minutes.
Interventions
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Reflectance Confocal Imaging
Microscopic images taken during routine colposcopy where disinfected probe inserted into vagina and placed against cervix, 1-3 regions imaged (2 abnormal and one normal), and each taking about 1-2 minutes.
Eligibility Criteria
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Inclusion Criteria
* Subjects must sign an informed consent indicating awareness of the investigational nature of this study.
Exclusion Criteria
18 Years
FEMALE
No
Sponsors
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National Cancer Institute (NCI)
NIH
M.D. Anderson Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Michele Follen, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
M.D. Anderson Cancer Center
Locations
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Lyndon B. Johnson Hospital
Houston, Texas, United States
U. T. Health Science Center
Houston, Texas, United States
U.T.M.D. Anderson Cancer Center
Houston, Texas, United States
British Columbia Cancer Research Center
Vancouver, British Columbia, Canada
Countries
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Related Links
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UT MD Anderson Cancer Center
Other Identifiers
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CA82880
Identifier Type: -
Identifier Source: secondary_id
ID01-555
Identifier Type: -
Identifier Source: org_study_id