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

This study has been terminated.
(No patients enrolled; study terminated.)
Sponsor:
Collaborator:
Information provided by:
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00503919
First received: July 17, 2007
Last updated: October 7, 2009
Last verified: September 2009

July 17, 2007
October 7, 2009
May 2007
February 2009   (final data collection date for primary outcome measure)
Multi-spectral Digital Colposcopy [ Time Frame: Extra 2 minutes to image during routine colposcopy procedure ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00503919 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Measurement of Digital Colposcopy for Fluorescence Spectroscopy of TNC Using a Second Device
A Pilot Study: Measurement of Digital Colposcopy for Fluorescence Spectroscopy of the Normal Cervix for Screening, Using a Second Generation 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.

Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Cervical Neoplasia
Procedure: Multi-spectral Digital Colposcopy (MDC)
Use of a digital camera and a special light to take pictures of the cervix and vagina.
Experimental: MDC
Multi-spectral Digital Colposcopy for Fluorescence Spectroscopy
Intervention: Procedure: Multi-spectral Digital Colposcopy (MDC)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
0
February 2009
February 2009   (final data collection date for primary outcome measure)

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.
Female
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00503919
2006-0810
No
Andrea Milbourne, MD, MS, BA/Assoc. Professor, UT MD Anderson Cancer Center
M.D. Anderson Cancer Center
National Cancer Institute (NCI)
Principal Investigator: Andrea Milbourne, MD M.D. Anderson Cancer Center
M.D. Anderson Cancer Center
September 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP