Pilot Study of a Digital Imaging Aid for Assessment of Cervical Dysplasia
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.
Observational
Observational Model: Case-Only, Time Perspective: Prospective
Evaluate whether a digital camera image can work as well as colposcopy at detecting precancerous tissue.
2 Year
No
Michele Follen, MD, PhD
Principal Investigator
M.D. Anderson Cancer Center
United States: Institutional Review Board
2007-0230
NCT00511758
June 2007
May 2009
Name | Location |
---|---|
U.T.M.D. Anderson Cancer Center | Houston, Texas 77030 |