Measurement of Digital Colposcopy for Fluorescence Spectroscopy of TNC Using a Second Device

Cervical Neoplasia Clinical Trial

Official title: A Pilot Study: Measurement of Digital Colposcopy for Fluorescence Spectroscopy of the Normal Cervix for Screening, Using a Second Generation Device

Status Withdrawn

Clinical Trial Summary

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).

Clinical Trial Description

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. ;

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Cervical Neoplasia

• NCT number: NCT00503919
• Study type: Interventional
• Source: M.D. Anderson Cancer Center
• Status: Withdrawn
• Phase: Phase 1
• Start date: May 2007
• Completion date: February 2009