Pathological Correlation of Colposcopically Directed Biopsies to Fluorescence EEM of the Normal Human Cervix
- Identify potential improvements in noninvasive methods of diagnosing dysplasia and
neoplasia of the cervix using fluorescence and reflectance spectroscopy in healthy
participants with a history of normal pap smears.
- Determine the reflection and fluorescence spectra of in vivo samples of the normal
- Refine the detection of cervical lesions by fluorescence spectroscopy in these
participants using improved classification of normal columnar tissue and non-neoplastic
tissue with inflammation.
- Determine and validate the wavelength selections for spectroscopic diagnosis derived
from in vitro measurements from these participants.
- Compare specific tissue sections from these participants with their excitation-emission
matrices in order to identify the cell types contributing to the signal.
OUTLINE: Participants undergo placement of a fiber optic probe on one normal columnar cell
site and one normal squamous cell site of the cervix during colposcopy*. The probe delivers
laser light at a specific excitation wavelength and collects fluorescence from the entire
emission wavelength range from the mucosa. Participants undergo biopsies of both sites.
NOTE: *The columnar epithelium will not be colposcopically visible in all patients, in which
case 2 normal squamous sites will be measured
PROJECTED ACCRUAL: A total of 1,000 participants will be accrued for this study.
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Fluorescent Measurements of Cervix
Two fluorescent measurements of cervix, approximately 2.5 minutes each: 1)colposcopically normal columnar site, and 2) a colposcopically normal squamous site.
Participation complete after readings of several 2.5 minutes fluorescent measurements and biopsies taken during colposcopy.
Helen Rhodes, MD
M.D. Anderson Cancer Center
United States: Food and Drug Administration
|M. D. Anderson Cancer Center at University of Texas||Houston, Texas 77030-4009|