Reflectance Confocal Imaging in Cervical Cancer Patients

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.

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Key information

Conditions

Cervical Cancer Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Neoplasms Neoplasms by Site Precancerous Conditions Urogenital Diseases Urogenital Neoplasms Uterine Cervical Diseases Uterine Cervical Dysplasia Uterine Cervical Neoplasms Uterine Diseases Uterine Neoplasms

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

British Columbia Cancer Research Center, Vancouver, British Columbia, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Reflectance Confocal Imaging

Procedure

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.

Primary outcomes

Reflectance confocal images of cervical tissue in vivo

Time frame: 1-2 minutes during routine colposcopy

Sponsors and collaborators

Lead sponsor

M.D. Anderson Cancer Center

Other

Collaborators

National Cancer Institute (NCI)

Registry information

Official study title

Reflectance Confocal Imaging of Cervical Intraepithelial Neoplasia (CIN)

Important dates

Study start: 2001
Primary completion: 2007
Study completion: 2007
First posted: Jul 23, 2007
Registry last updated: Aug 1, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed