Trial Information

A Pilot Study: Measurement of Digital Colposcopy for Fluorescence Spectroscopy of Cervical Intraepithelial Neoplasia Using a Second Generation Device

OBJECTIVES:

- To identify potential improvements for a noninvasive method of diagnosing cervical
dysplasia and neoplasia using the Multispectral Digital Colposcope (MDC), a device that
uses fluorescence and reflectance spectroscopy to compare images with histopathologic
mapping of the cervical epithelium.

- To measure MDC images in vivo of the cervix using a modified device that makes
measurements in seconds rather than over 2 minutes before and after acetic acid.

- To evaluate, preliminarily, the effect of the fading of acetic acid in the image
contrast obtained over time to see if this fading can predict the grade of
intraepithelial neoplasia.

- To evaluate mapping of the cervix so that software can reconstruct the cervical
epithelial map to compare the map with routine colposcopic images as well as with those
from the MDC.

- To compare, preliminarily, MDC performance with colposcopy and pathologic analysis of
tissue removed after colposcopy in the form of the loop electrosurgical excision
procedure (LEEP).

OUTLINE: This is a multicenter study.

Patients undergo routine colposcopy as part of their regular colposcopic evaluation. The
digital colposcope is used to take images of the vagina and cervix, pre- and post-acetic
acid, using white, green, and blue light. Colposcopically abnormal areas are biopsied; a
normal area may also be biopsied. Patients undergoing loop electrosurgical excision
procedure (LEEP) may undergo one additional biopsy of a colposcopically normal site.