Reflectance Confocal Imaging in Cervical Cancer Patients

Completed

• Conditions: Cervical Cancer
• Interventions: Procedure: Reflectance Confocal Imaging

• Registration Number: NCT00505726
• Lead Sponsor: M.D. Anderson Cancer Center

Brief Summary

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.

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 Timeline

• Study Start: 2001-11
• Study First Submitted: 2007-07-20
• Study First Submitted QC: 2007-07-20
• Study First Posted: 2007-07-23
• Primary Completion: 2007-09
• Study Completion: 2007-09
• Status Verified: 2012-07
• Last Update Submitted: 2012-07-31
• Last Update Posted: 2012-08-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 39

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.

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Exclusion Criteria

• Pregnant individuals will be ineligible for this study.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Confocal Microscopy	Reflectance Confocal Imaging	-

Primary Outcome Measures

Name	Time	Method
Reflectance confocal images of cervical tissue in vivo	1-2 minutes during routine colposcopy

Trial Locations

Locations (4)

British Columbia Cancer Research Center; 🇨🇦 Vancouver, British Columbia, Canada

U. T. Health Science Center; 🇺🇸 Houston, Texas, United States

Lyndon B. Johnson Hospital; 🇺🇸 Houston, Texas, United States

U.T.M.D. Anderson Cancer Center; 🇺🇸 Houston, Texas, United States