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Pilot Study of a Digital Imaging Aid for Assessment of Cervical Dysplasia
The overall objective of this study is to evaluate whether polarized or green filtered digital imaging can assist clinicians to screen for premalignant lesions in the cervix. The specific aims of the study are: * To compare polarized and green filtered digital images of the cervix, to standard white light images, colposcopic evaluation and to pathologic analysis of biopsied tissue. * To develop algorithms to discriminate between normal and abnormal tissue based on digital images of the cervix. * To analyze digital images to determine which types of optical information yield the most diagnostically useful data.
If you agree to take part in this study, digital imaging will be performed for research purposes, after your routine colposcopy of your cervix. VISUAL DETECTION OF PRECANCEROUS LESIONS: Reflectance (the ability of an area to reflect light) imaging helps doctors visually tell the difference between precancerous tissue, cancerous tissue, and normal tissue in the cervix. Researchers want find out whether a digital camera image can be as effective as colposcopy at screening for precancerous tissue. STUDY PARTICIPATION: You will be seen in the clinic during a routine visit. Your cervix will first be examined by the clinician using a standard white light headlamp, and the image will be recorded. Your cervix will then be re-examined with the digital camera, which will involve the use of different types of light (standard white light, green filtered light, cross and parallel polarized light). These digital images will be taken before and after acetic acid (vinegar) is applied. Researchers will use these images to make comparison studies with the colposcopy procedure. LENGTH OF STUDY: Your participation will be finished on this study once your cervix has been examined with the digital camera. This is an investigational study. Up to patients 20 will take part in this study. All will be enrolled at M. D. Anderson.
Age
18 - No limit years
Sex
FEMALE
Healthy Volunteers
No
U.T.M.D. Anderson Cancer Center
Houston, Texas, United States
Start Date
June 1, 2007
Primary Completion Date
May 1, 2009
Completion Date
May 1, 2009
Last Updated
August 1, 2012
3
ACTUAL participants
Digital Imaging
PROCEDURE
Lead Sponsor
M.D. Anderson Cancer Center
Collaborators
NCT05606133
NCT05132114
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT06598176