Reflectance Confocal Imaging in Cervical Cancer Patients - Full Text View

Sponsors and Collaborators:	M.D. Anderson Cancer Center National Cancer Institute (NCI)
Information provided by:	M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:	NCT00505726

Purpose

Primary Objectives:

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

Condition	Intervention	Phase
Cervical Cancer	Procedure: Reflectance Confocal Imaging	Phase I

MedlinePlus related topics: Cancer

U.S. FDA Resources

Study Type:	Observational
Study Design:	Natural History, Longitudinal, Defined Population, Prospective Study
Official Title:	Reflectance Confocal Imaging of Cervical Intraepithelial Neoplasia (CIN)

Further study details as provided by M.D. Anderson Cancer Center:

Estimated Enrollment:	72
Study Start Date:	November 2001

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. The cost of the normal biopsy will be paid for by the grant. About 72 women will take part in this study. About 18 will be enrolled at M. D. Anderson.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00505726

Locations

United States, Texas
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
Houston, Texas, United States, 77030
Canada, British Columbia
British Columbia Cancer Research Center
Vancouver, British Columbia, Canada

Sponsors and Collaborators

M.D. Anderson Cancer Center

National Cancer Institute (NCI)

Investigators

Principal Investigator:

Michele Follen, MD, PhD

U.T.M.D. Anderson Cancer Center

More Information

Study ID Numbers:	ID01-555
Study First Received:	July 20, 2007
Last Updated:	September 26, 2007
ClinicalTrials.gov Identifier:	NCT00505726
Health Authority:	United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:

Cervical Intraepithelial Neoplasia
Cervical Cancer
Reflectance Confocal Imaging
Colposcopy

Study placed in the following topic categories:

Cervical intraepithelial neoplasia
Carcinoma in Situ
Neoplasms, Glandular and Epithelial
Carcinoma
Cervical Intraepithelial Neoplasia

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on January 16, 2009