Molecular Imaging for Detection of Cervical Intraepithelial Neoplasia
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Purpose
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:
- Obtain cervical specimens from women with high grade squamous intraepithelial lesions (HGSILs) being treated with the loop electrosurgical excision procedure (LEEP).
- 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.
- 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.
| Condition | Intervention |
|---|---|
|
Cervical Cancer |
Procedure: Loop Electrosurgical Excision Procedure (LEEP) |
| Study Type: | Observational |
| Study Design: | Observational Model: Case-Only Time Perspective: Prospective |
| Official Title: | A Feasibility Study of Molecular Imaging for Detection of Cervical Intraepithelial Neoplasia |
- To learn if a new type of contrast agent (a dye used in certain types of scans and microscope studies) can be used to detect cervical cancer and precancerous lesions better than standard contrast agents. [ Time Frame: 4 Years ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples With DNA
Tissue sample removal from the cervix using LEEP during the scheduled colposcopy.
| Enrollment: | 30 |
| Study Start Date: | March 2005 |
| Study Completion Date: | February 2008 |
| Primary Completion Date: | February 2008 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
1
Patients with cervical cancer scheduled to be treated with the LEEP procedure.
|
Procedure: Loop Electrosurgical Excision Procedure (LEEP)
Tissue sample removed from cervix using LEEP and contrast agent.
Other Name: LEEP
|
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 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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Patients with cervical cancer scheduled to be treated with the LEEP procedure.
Inclusion Criteria:
- 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.
Exclusion Criteria:
- Patients who are younger than 18 years of age.
- Patients who are pregnant.
- Patients who are HIV positive.
Contacts and Locations| United States, Texas | |
| U.T.M.D. Anderson Cancer Center | |
| Houston, Texas, United States, 77030 | |
| UT Health Science Center-Houston | |
| Houston, Texas, United States, 77030 | |
| Lyndon B. Johnson Hospital | |
| Houston, Texas, United States, 77030 | |
| Canada, British Columbia | |
| British Columbia Cancer Agency | |
| Vancouver, British Columbia, Canada | |
| Principal Investigator: | Michele Follen, MD, PhD | M.D. Anderson Cancer Center |
More Information
Additional Information:
Publications:
| Responsible Party: | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00511615 History of Changes |
| Other Study ID Numbers: | 2004-0862 |
| Study First Received: | August 2, 2007 |
| Last Updated: | July 31, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by M.D. Anderson Cancer Center:
|
Cervical Intraepithelial Neoplasia Loop Electrosurgical Excision Procedure Cervical Cancer |
Colposcopy Molecular Imaging LEEP |
Additional relevant MeSH terms:
|
Neoplasms Uterine Cervical Neoplasms Cervical Intraepithelial Neoplasia Carcinoma in Situ Uterine Neoplasms Genital Neoplasms, Female Urogenital Neoplasms |
Neoplasms by Site Uterine Cervical Diseases Uterine Diseases Genital Diseases, Female Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type |
ClinicalTrials.gov processed this record on May 23, 2013