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
  Purpose

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 Intervention Phase
Cervical Neoplasia
Procedure: Multi-spectral Digital Colposcopy (MDC)
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • Multi-spectral Digital Colposcopy [ Time Frame: Extra 2 minutes to image during routine colposcopy procedure ] [ Designated as safety issue: No ]

Enrollment: 0
Study Start Date: May 2007
Study Completion Date: February 2009
Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00503919

Locations
United States, Texas
U.T. M.D. Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Principal Investigator: Andrea Milbourne, MD M.D. Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: Andrea Milbourne, MD, MS, BA/Assoc. Professor, UT MD Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00503919     History of Changes
Other Study ID Numbers: 2006-0810
Study First Received: July 17, 2007
Results First Received: September 4, 2009
Last Updated: October 7, 2009
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Neoplasms

ClinicalTrials.gov processed this record on October 21, 2014