Molecular Imaging for Detection of Cervical Intraepithelial Neoplasia
NCT ID: NCT00511615
Last Updated: 2012-08-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
30 participants
OBSERVATIONAL
2005-03-31
2008-02-29
Brief Summary
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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.
Detailed Description
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The tissue that is removed will be taken to a room where the researchers will use a special microscope to look at the tissue before and after the new contrast agent is painted on the surface of the tissue. After the tissue samples are looked at, they will be sent to the lab for routine tests (as part of your standard of care).
You will require a LEEP whether you participate in this study or not. The tissue removal is a standard part of the LEEP. The experimental portion of this study is the use of the contrast agent. Once that portion is complete, the tissue will be tested as per standard of care. The tissue will not be used for any other research testing.
You will not be told of any of the experimental findings with the contrast agent. However, your doctor and/or nurse practitioner will be told the results of the routine tests, and they will give these results to you.
This is an investigational study. The LEEP is considered standard of care and any charges associated with the LEEP will be the responsibility of you and/or your insurance provider. Up to 80 women will take part in this multicenter study. Up to 40 will be enrolled at M.D. Anderson.
Conditions
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Keywords
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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1
Patients with cervical cancer scheduled to be treated with the LEEP procedure.
Loop Electrosurgical Excision Procedure (LEEP)
Tissue sample removed from cervix using LEEP and contrast agent.
Interventions
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Loop Electrosurgical Excision Procedure (LEEP)
Tissue sample removed from cervix using LEEP and contrast agent.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Patients who are not pregnant.
3. Patients who are not HIV positive.
4. Patients who are scheduled to be treated for SIL with LEEP.
Exclusion Criteria
2. Patients who are pregnant.
3. Patients who are HIV positive.
18 Years
FEMALE
No
Sponsors
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National Cancer Institute (NCI)
NIH
M.D. Anderson Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Michele Follen, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
M.D. Anderson Cancer Center
Locations
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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
Countries
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References
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Aaron J, Nitin N, Travis K, Kumar S, Collier T, Park SY, Jose-Yacaman M, Coghlan L, Follen M, Richards-Kortum R, Sokolov K. Plasmon resonance coupling of metal nanoparticles for molecular imaging of carcinogenesis in vivo. J Biomed Opt. 2007 May-Jun;12(3):034007. doi: 10.1117/1.2737351.
Related Links
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UT MD Anderson Cancer Center Website
Other Identifiers
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2004-0862
Identifier Type: -
Identifier Source: org_study_id