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NCT00511615 · ClinicalTrials.gov registry record
Molecular Imaging for Detection of Cervical Intraepithelial Neoplasia
A clinical trial, sponsored by M.D. Anderson Cancer Center.
- Completed
- Registry status
- 30
- Enrollment target
NCT00511615: Completed study, sponsored by M.D. Anderson Cancer Center.
NCT00511615 is a clinical trial that has completed, run by M.D. Anderson Cancer Center. The registered enrollment target is 30 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00511615 has completed, sponsored by M.D. Anderson Cancer Center.
- COMPLETED
- Registry status
- 30 participants
- Enrollment target
Study Summary
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.
Interventions
- PROCEDURE Loop Electrosurgical Excision Procedure (LEEP)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2005-03 |
| Est. Completion | 2008-02 |
What the finished NCT00511615 record still lists
NCT00511615 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 30 participants, a relatively small participant target.
The record links to 0 conditions, and to 1 intervention - of which Loop Electrosurgical Excision Procedure (LEEP) is the first listed.
NCT00511615 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00511615 about?
NCT00511615 is a clinical study titled "Molecular Imaging for Detection of Cervical Intraepithelial Neoplasia". 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 invest...
What is the current status of trial NCT00511615?
This trial is currently completed. The enrollment target is 30 participants. The study started on 2005-03. Estimated completion is 2008-02.
What interventions are being tested in trial NCT00511615?
The interventions under investigation include: Loop Electrosurgical Excision Procedure (LEEP) (PROCEDURE).
Who is sponsoring clinical trial NCT00511615?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
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