Clinical trial NCT00505726: Reflectance Confocal Imaging in Cervical Cancer Patients
Official title: Reflectance Confocal Imaging of Cervical Intraepithelial Neoplasia (CIN)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cervical Cancer
Keywords: Cervical Intraepithelial Neoplasia
Cervical Cancer
Reflectance Confocal Imaging
Colposcopy
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2007-07-23
Enrollment: 39
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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.

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.

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 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.

Primary outcomes:
measure: Reflectance confocal images of cervical tissue in vivo
timeFrame: 1-2 minutes during routine colposcopy
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: Lyndon B. Johnson Hospital
state: Texas
city: Houston
country: United States
facility: U. T. Health Science Center
state: Texas
city: Houston
country: United States
facility: U.T.M.D. Anderson Cancer Center
state: Texas
city: Vancouver
country: Canada
facility: British Columbia Cancer Research Center
state: British Columbia
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Michele Follen, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: