Reflectance Confocal Imaging in Cervical Cancer Patients

Completed

Conditions studied: Cervical Cancer

In brief

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.

Key facts

Study ID

NCT00505726

Run by

M.D. Anderson Cancer Center

People needed

39

Starts

2001-11-01

Expected to finish

2007-09-01

Last updated by the study team

2012-08-01

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• Pregnant individuals will be ineligible for this study.

Where it is running

• Lyndon B. Johnson Hospital — Houston, Texas, United States
• U. T. Health Science Center — Houston, Texas, United States
• U.T.M.D. Anderson Cancer Center — Houston, Texas, United States
• British Columbia Cancer Research Center — Vancouver, British Columbia, Canada

Full record on ClinicalTrials.gov

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