COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC:

Get the latest research information from NIH: Menu

Reflectance Confocal Imaging in Cervical Cancer Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00505726
Recruitment Status : Completed
First Posted : July 23, 2007
Last Update Posted : August 1, 2012
National Cancer Institute (NCI)
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Cervical Cancer Procedure: Reflectance Confocal Imaging

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.

Layout table for study information
Study Type : Observational
Actual Enrollment : 39 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Reflectance Confocal Imaging of Cervical Intraepithelial Neoplasia (CIN)
Study Start Date : November 2001
Actual Primary Completion Date : September 2007
Actual Study Completion Date : September 2007

Group/Cohort Intervention/treatment
Confocal Microscopy 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.

Primary Outcome Measures :
  1. Reflectance confocal images of cervical tissue in vivo [ Time Frame: 1-2 minutes during routine colposcopy ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Women, 18 years of age or older, who are already scheduled for colposcopy to detect or treat cervical lesions.

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00505726

Layout table for location information
United States, Texas
Lyndon B. Johnson Hospital
Houston, Texas, United States, 77030
U. T. Health Science Center
Houston, Texas, United States, 77030
U.T.M.D. Anderson Cancer 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)
Layout table for investigator information
Principal Investigator: Michele Follen, MD, PhD M.D. Anderson Cancer Center
Additional Information:
Layout table for additonal information
Responsible Party: M.D. Anderson Cancer Center Identifier: NCT00505726    
Other Study ID Numbers: ID01-555
First Posted: July 23, 2007    Key Record Dates
Last Update Posted: August 1, 2012
Last Verified: July 2012
Keywords provided by M.D. Anderson Cancer Center:
Cervical Intraepithelial Neoplasia
Cervical Cancer
Reflectance Confocal Imaging
Additional relevant MeSH terms:
Layout table for MeSH terms
Uterine Cervical Neoplasms
Cervical Intraepithelial Neoplasia
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female
Carcinoma in Situ
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type