Reflectance Confocal Imaging in Cervical Cancer Patients

Cervical Cancer Clinical Trial

Official title:

Reflectance Confocal Imaging of Cervical Intraepithelial Neoplasia (CIN)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00505726
• Other study ID #: ID01-555
• Secondary ID: CA82880
• Status: Completed
• Phase: Phase 1
• First received: July 20, 2007
• Last updated: July 31, 2012
• Start date: November 2001
• Est. completion date: September 2007

Study information

• Verified date: July 2012
• Source: M.D. Anderson Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 39
• Est. completion date: September 2007
• Est. primary completion date: September 2007
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Cervical Cancer
• Cervical Intraepithelial Neoplasia
• Uterine Cervical Neoplasms

Intervention

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.

Locations

Country	Name	City	State
Canada	British Columbia Cancer Research Center	Vancouver	British Columbia
United States	Lyndon B. Johnson Hospital	Houston	Texas
United States	U. T. Health Science Center	Houston	Texas
United States	U.T.M.D. Anderson Cancer Center	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
M.D. Anderson Cancer Center	National Cancer Institute (NCI)

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reflectance confocal images of cervical tissue in vivo		1-2 minutes during routine colposcopy	No

External Links

•   UT MD Anderson Cancer Center