Ignite Creation Date:
2024-05-05 @ 6:36 PM
Last Modification Date:
2024-10-26 @ 9:35 AM
Study NCT ID:
NCT00511615
Status:
COMPLETED
Last Update Posted:
2012-08-01
First Post:
2007-08-02
Brief Title:
Molecular Imaging for Detection of Cervical Intraepithelial Neoplasia
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
A Feasibility Study of Molecular Imaging for Detection of Cervical Intraepithelial Neoplasia
Status:
COMPLETED
Status Verified Date:
2012-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The hypothesis of this research project is that topical application of the anti-EGFR or anti-E6E7 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 HE and immunohistochemical staining for EGFR or E6E7 The images will be reconstructed into a two dimensional map delineating areas of Cervical Intraepithelial Neoplasia CIN and of EGFR or E6E7 overexpression Maps of the pathology will be compared to those obtained from the intact cervix exposed to the contrast agent
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 HE and immunohistochemical staining for EGFR or E6E7 The images will be reconstructed into a two dimensional map delineating areas of Cervical Intraepithelial Neoplasia CIN and of EGFR or E6E7 overexpression Maps of the pathology will be compared to those obtained from the intact cervix exposed to the contrast agent
Detailed Description:
During your scheduled colposcopy a sample of tissue will be removed from your cervix using the loop electrosurgical excision procedure LEEP The LEEP is the standard of care treatment for the precancerous condition on your cervix The details of the procedure will be covered in another consent form Before the LEEP a photograph will be taken of the cervix This photograph will be taken for research purposes so that researchers will have a photograph to compare to the images taken with the MDC and Confocal
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 andor 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 andor your insurance provider Up to 80 women will take part in this multicenter study Up to 40 will be enrolled at MD Anderson
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 andor 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 andor your insurance provider Up to 80 women will take part in this multicenter study Up to 40 will be enrolled at MD Anderson
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None