Reflectance Confocal Imaging in Cervical Cancer Patients
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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:
- 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 1 |
| Study Type: | Observational |
| Study Design: | Observational Model: Case-Only Time Perspective: Prospective |
| Official Title: | Reflectance Confocal Imaging of Cervical Intraepithelial Neoplasia (CIN) |
- 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 |
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.
Contacts and 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 | |
| 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 May 23, 2013