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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Patients with cervical cancer scheduled to be treated with the LEEP procedure. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Loop Electrosurgical Excision Procedure (LEEP) | Procedure | Tissue sample removed from cervix using LEEP and contrast agent. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 4 Years |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with cervical cancer scheduled to be treated with the LEEP procedure.
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| Name | Affiliation | Role |
|---|---|---|
| Michele Follen, MD, PhD | M.D. Anderson Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lyndon B. Johnson Hospital | Houston | Texas | 77030 | United States | ||
| U.T.M.D. Anderson Cancer Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17614715 | Background | 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. |
| Label | URL |
|---|---|
| UT MD Anderson Cancer Center Website | View source |
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| ID | Term |
|---|---|
| D002583 | Uterine Cervical Neoplasms |
| D002578 | Uterine Cervical Dysplasia |
| ID | Term |
|---|---|
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
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Tissue sample removal from the cervix using LEEP during the scheduled colposcopy.
| Houston |
| Texas |
| 77030 |
| United States |
| UT Health Science Center-Houston | Houston | Texas | 77030 | United States |
| British Columbia Cancer Agency | Vancouver | British Columbia | Canada |
| D009369 |
| Neoplasms |
| D002577 | Uterine Cervical Diseases |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D011230 | Precancerous Conditions |