Spots Global Cancer Trial Database for Reflectance Confocal Imaging in Cervical Cancer Patients

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Trial Identification

Brief Title: Reflectance Confocal Imaging in Cervical Cancer Patients

Official Title: Reflectance Confocal Imaging of Cervical Intraepithelial Neoplasia (CIN)

Study ID: NCT00505726

Conditions

Cervical Cancer

Interventions

Reflectance Confocal Imaging

Study Description

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.