Molecular Imaging for Detection of Cervical Intraepithelial Neoplasia

Completed

Conditions studied: Cervical Cancer

In brief

The hypothesis of this research project is that topical application of the anti-EGFR or anti-E6/E7 contrast agents followed by optical imaging will yield images that reflect spatial variations in expression that correlate with the presence of cervical precancer. To gather feasibility data the investigators will: 1. Obtain cervical specimens from women with high grade squamous intraepithelial lesions (HGSILs) being treated with the loop electrosurgical excision procedure (LEEP). 2. After Loop Electrosurgical Excision Procedure (LEEP) is performed, obtain low and high resolution optical images before and after applying contrast agents topically to the epithelial surface of the tissue for 30 minutes before rinsing. 3. Submit the specimen for histology, and have it sectioned and stained using both H\&E and immunohistochemical staining for EGFR or E6/E7. The images will be reconstructed into a two dimensional map delineating areas of Cervical Intraepithelial Neoplasia (CIN) and of EGFR or E6/E7 overexpression. Maps of the pathology will be compared to those obtained from the intact cervix exposed to the contrast agent.

Key facts

Study ID

NCT00511615

Run by

M.D. Anderson Cancer Center

People needed

30

Starts

2005-03-01

Expected to finish

2008-02-01

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…

• Patients who are 18 years of age or older.
• Patients who are not pregnant.
• Patients who are not HIV positive.
• Patients who are scheduled to be treated for SIL with LEEP.

You may not qualify if…

• Patients who are younger than 18 years of age.
• Patients who are pregnant.
• Patients who are HIV positive.

Where it is running

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

Full record on ClinicalTrials.gov

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