Reflectance Confocal Imaging in Cervical Cancer Patients

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00505726
First received: July 20, 2007
Last updated: July 31, 2012
Last verified: July 2012
  Purpose

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 Intervention Phase
Cervical Cancer
Procedure: Reflectance Confocal Imaging
Phase 1

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Reflectance Confocal Imaging of Cervical Intraepithelial Neoplasia (CIN)

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Reflectance confocal images of cervical tissue in vivo [ Time Frame: 1-2 minutes during routine colposcopy ] [ Designated as safety issue: No ]

Enrollment: 39
Study Start Date: November 2001
Study Completion Date: September 2007
Primary Completion Date: September 2007 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders 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.

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
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, see Learn About Clinical Studies.

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
Investigators
Principal Investigator: Michele Follen, MD, PhD M.D. Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00505726     History of Changes
Other Study ID Numbers: ID01-555, CA82880
Study First Received: July 20, 2007
Last Updated: July 31, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:
Cervical Intraepithelial Neoplasia
Cervical Cancer
Reflectance Confocal Imaging
Colposcopy

Additional relevant MeSH terms:
Uterine Cervical Neoplasms
Cervical Intraepithelial Neoplasia
Carcinoma in Situ
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on July 22, 2014