Measurement of Digital Colposcopy for Fluorescence Spectroscopy of TNC Using a Second Device
Measurement of Digital Colposcopy for Fluorescence Spectroscopy of TNC Using a Second Device
The overall objective of this study is to identify potential improvements for a noninvasive
 method of diagnosing dysplasia and neoplasia in the cervix using Multi-spectral Digital
 Colposcopy (MDC), a device that uses fluorescence and reflectance spectroscopy to compare
 images to histopathologic mapping of the cervical epithelium.

 Primary Objective:

 -To measure Multi-spectral Digital Colposcopy images in vivo of the cervix both before and
 after acetic acid in a screening population.This is a second generation research device with
 low significant risk for which we are studying MDC.

 Secondary Objectives:

 1. To evaluate the effect of the fading of acetic acid in the image contrast obtained over
 time to see if this fading can predict the presence of any neoplasia.

 2. To evaluate mapping the cervix so that software can reconstruct the cervical epithelial
 map as evaluated by a Papanicolaou Smear to compare to routine colposcopic images as
 well as those from the Multi-spectral Digital Colposcopy (MDC).
A colposcopy is an exam of the vagina and cervix using a magnifying lens. A multi-spectral
 digital colposcopy uses a digital camera and a special light to take pictures of the cervix
 and vagina.

 Before taking part in this study, you will have a complete medical history recorded. You will
 have a physical exam and a pap smear. Women who are able to have children must have a
 negative urine pregnancy test.

 You will then have a multi-spectral digital colposcopy performed during the routine
 colposcopy in the outpatient clinic. A multi-spectral digital colposcopy device will shine
 light on the cervix and vagina and take several pictures. The pictures will be used by the
 doctors to check the cells and structure of the tissue. After the first set of pictures,
 acetic acid (vinegar) will be applied to the cervix so any lesions would show up better.
 Application of acetic acid is a normal part of the colposcopy and not part of the research.
 About 1-2 minutes later, more pictures will be taken.

 If the acetic acid/colposcopy show abnormal cells, you will have a biopsy of the cervical
 canal.

 If the acetic acid /colposcopy show normal cells, no biopsy will be taken.

 Once you have completed the colposcopy with or without the biopsy of the cervical canal, your
 participation on this study is complete.

 If either your Pap smear or biopsy of the cervical canal is abnormal, the study doctor/staff
 will recommend further care or treatment.
Inclusion Criteria:

 1. Women 18 years of age or older.

 2. Women who have been referred for screening at U.T.M.D. Anderson Hospital, Houston, TX
 USA; U.T. Health Science Center-Houston,TX USA; Lyndon B. Johnson General Hospital,
 Houston, TX USA; British Columbia Cancer Agency, Vancouver, British Columbia, Canada;
 and the University College Hospital, Ibadan, Oyo State, Nigeria, Africa Cervical
 Screening Clinics, Family Planning Clinics or Gynecology Clinics.

 3. Patients must sign an informed consent indicating awareness of the investigational
 nature of the study.

 Exclusion Criteria:

 1. Patients will be considered ineligible if they are pregnant.

 2. If they have a history of an abnormal Pap or a treatment to the cervix.