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

NCT00503919 · Status: WITHDRAWN · Phase: PHASE1 · Type: INTERVENTIONAL

Last updated 2016-04-08

No results posted yet for this study

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).

Conditions

  • Cervical Neoplasia

Interventions

PROCEDURE

Multi-spectral Digital Colposcopy (MDC)

Use of a digital camera and a special light to take pictures of the cervix and vagina.

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • M.D. Anderson Cancer Center

    lead OTHER

Principal Investigators

  • Andrea Milbourne, MD · M.D. Anderson Cancer Center

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2007-05-31
Primary Completion
2009-02-28
Completion
2009-02-28

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00503919 on ClinicalTrials.gov