Cervical Cancer Clinical Trial
Official title:
A Pilot Study: Measurement of Digital Colposcopy for Fluorescence Spectroscopy of Cervical Intraepithelial Neoplasia
The overall objective of this study is to identify potential improvements for a noninvasive
method of diagnosing dysplasia and neoplasia in the cervix using digital colposcopy for
colposcopy for fluorescence spectroscopy.
Other Objectives:
- To measure digital fluorescence and reflectance images in vivo of sites in the human
cervix.
- To evaluate the effect of acetic acid in the image contrast obtained.
- Compare the device performance to colposcopy and pathologic analysis of tissue removed
at colposcopy.
DCF may provide a better way to detect or treat lesions of the cervix. Women in the study
will already be scheduled for colposcopy to detect or treat lesions of the cervix. (A
colposcopy is an exam of the vagina and cervix using a magnifying lens).
DCF will be done during the routine colposcopy in the outpatient clinic. A digital
colposcope (DC) device will be used to take a sequence of images of the cervix and vagina.
(A DC is a digital camera connected to the colposcope with a specialized light source. It
will shine light on the cervix and acquire a sequence images). The images will tell doctors
about the cells and structure of the tissue. After the first set of images, acetic acid will
be applied to the cervix so that lesions show up better, and 1-2 minutes later more readings
will be taken.
Small samples of areas of abnormal tissue will be removed during colposcopy. Taking these
tissue samples is a routine part of this type of exam. If patients are having colposcopy and
loop electrosurgical excision procedure (LEEP treatment, one sample of normal tissue will be
taken. (The cervix will be numbed for this procedure.) DCF images will be compared with lab
findings from these samples. Before DCF is done, as standard of care, patients will have a
complete history and physical exam, urine pregnancy test, pap smear, and cultures for
gonorrhea, chlamydia and viral testing.
This is an investigational study. About 114 women will take part in this study. About 22
will be enrolled at M. D. Anderson.
;
Observational Model: Case-Only, Time Perspective: Prospective
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