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Reflectance Confocal Imaging in Cervical Cancer Patients

NCT00505726 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 39

Last updated 2012-08-01

No results posted yet for this study

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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • M.D. Anderson Cancer Center

    lead OTHER

Principal Investigators

  • Michele Follen, MD, PhD · M.D. Anderson Cancer Center

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2001-11-30
Primary Completion
2007-09-30
Completion
2007-09-30

Countries

  • United States
  • Canada

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00505726 on ClinicalTrials.gov