Reflectance Confocal Imaging in Cervical Cancer Patients

July 31, 2012 updated by: M.D. Anderson Cancer Center

Reflectance Confocal Imaging of Cervical Intraepithelial Neoplasia (CIN)

The goal of this clinical research study is to see if reflectance confocal microscopy works as well as standard methods to detect cancer of the cervix or precancerous lesions.

Primary Objectives:

  1. To identify potential clinical advantages for a noninvasive method of diagnosing dysplasia and neoplasia in the cervix using reflectance confocal microscopy.
  2. To obtain real time reflected light images in vivo of sites in the human cervix.
  3. To access the effects of acetic acid as a contrast agent for in vivo reflectance confocal imaging.
  4. Evaluate the depth of penetration for the fiber optic confocal device and analyze the diagnostic value of images taken from different depths.
  5. Determine the sensitivity and specificity of this device for the diagnosis of CIN.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Confocal microscopy may be a new way to detect lesions of the cervix quickly without removing a tissue sample. Women in the study will already be scheduled for colposcopy to detect or treat cervical lesions. (A colposcopy is an exam of the vagina and cervix using a magnifying lens.)

Microscopic images will be taken during the routine colposcopy in the outpatient clinic. A disinfected probe will be inserted into the vagina and placed against the cervix. . The probe sends out laser light and detects reflected light from the tissue. Images of cervical tissue will be formed and displayed on a computer monitor. 1-3 regions of the cervix will be imaged (2 abnormal and one normal), and each will take about 1-2 minutes.

Each imaged site will be biopsied. The biopsies will be analyzed by the research pathologist. The results will be available to participants in the event that care needs to be given. Total participation in this study will be only a few minutes.

This is an investigational study. About 72 women will take part in this study. About 18 will be enrolled at M. D. Anderson.

Study Type

Observational

Enrollment (Actual)

39

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada
        • British Columbia Cancer Research Center
  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • U.T.M.D. Anderson Cancer Center
      • Houston, Texas, United States, 77030
        • Lyndon B. Johnson Hospital
      • Houston, Texas, United States, 77030
        • U. T. Health Science Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Women, 18 years of age or older, who are already scheduled for colposcopy to detect or treat cervical lesions.

Description

Inclusion Criteria:

  • Subjects will be individuals 18 years of age or older, who have voluntarily responded to advertisement in the form of posted flyers or word of mouth.
  • Subjects must sign an informed consent indicating awareness of the investigational nature of this study.

Exclusion Criteria:

  • Pregnant individuals will be ineligible for this study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Confocal Microscopy
Procedure: Reflectance Confocal Imaging
Microscopic images taken during routine colposcopy where disinfected probe inserted into vagina and placed against cervix, 1-3 regions imaged (2 abnormal and one normal), and each taking about 1-2 minutes.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Reflectance confocal images of cervical tissue in vivo
Time Frame: 1-2 minutes during routine colposcopy
1-2 minutes during routine colposcopy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

M.D. Anderson Cancer Center

Collaborators

National Cancer Institute (NCI)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2001

Primary Completion (Actual)

September 1, 2007

Study Completion (Actual)

September 1, 2007

Study Registration Dates

First Submitted

July 20, 2007

First Submitted That Met QC Criteria

July 20, 2007

First Posted (Estimate)

July 23, 2007

Study Record Updates

Last Update Posted (Estimate)

August 1, 2012

Last Update Submitted That Met QC Criteria

July 31, 2012

Last Verified

July 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ID01-555
  • CA82880

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe