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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00503919
Recruitment Status : Withdrawn (Study closed early with no enrollment.)
First Posted : July 19, 2007
Last Update Posted : April 8, 2016
National Cancer Institute (NCI)
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Brief 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).

Condition or disease Intervention/treatment Phase
Cervical Neoplasia Procedure: Multi-spectral Digital Colposcopy (MDC) Phase 1

Detailed 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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: A Pilot Study: Measurement of Digital Colposcopy for Fluorescence Spectroscopy of the Normal Cervix for Screening, Using a Second Generation Device
Study Start Date : May 2007
Actual Primary Completion Date : February 2009
Actual Study Completion Date : February 2009

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: MDC
Multi-spectral Digital Colposcopy for Fluorescence Spectroscopy
Procedure: Multi-spectral Digital Colposcopy (MDC)
Use of a digital camera and a special light to take pictures of the cervix and vagina.

Primary Outcome Measures :
  1. Number of participants with abnormal cell detection before and after acetic acid/colposcopy using Multi-spectral Digital Colposcopy (MDC) [ Time Frame: Participation limited to Colposcopy visit, anticipate study completion in one day ]
    Measurements of normal sites during colposcopy before and after the application of acetic acid using Multi-spectral Digital Colposcopy (MDC) images in vivo of the cervix both before and after acetic acid. Three images (white, blue, and green light) compared before and after acetic acid placement, the images may be compared to pathology obtained from a Pap Smear taken to evaluate the performance of the instrument.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00503919

Sponsors and Collaborators
M.D. Anderson Cancer Center
National Cancer Institute (NCI)
Principal Investigator: Andrea Milbourne, MD M.D. Anderson Cancer Center

Additional Information:
Responsible Party: M.D. Anderson Cancer Center Identifier: NCT00503919     History of Changes
Other Study ID Numbers: 2006-0810
First Posted: July 19, 2007    Key Record Dates
Last Update Posted: April 8, 2016
Last Verified: September 2009

Keywords provided by M.D. Anderson Cancer Center:
Cervical dysplasia
Cervical neoplasia
Cervical intraepithelial neoplasia
Multi-spectral Digital Colposcopy
Acetic acid
Fluorescence Spectroscopy
Abnormal Pap Smear

Additional relevant MeSH terms: