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Molecular Imaging for Detection of Cervical Intraepithelial Neoplasia
This study is currently recruiting participants.
Verified by M.D. Anderson Cancer Center, August 2008
Sponsors and Collaborators: M.D. Anderson Cancer Center
National Cancer Institute (NCI)
Information provided by: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00511615
  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:

  1. Obtain cervical specimens from women with high grade squamous intraepithelial lesions (HGSILs) being treated with the loop electrosurgical excision procedure (LEEP).
  2. After 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 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

MedlinePlus related topics: Cancer
U.S. FDA Resources
Study Type: Observational
Study Design: Case-Only, Prospective
Official Title: A Feasibility Study of Molecular Imaging for Detection of Cervical Intraepithelial Neoplasia

Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • The goal of this laboratory research study is 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

Biospecimen Description:

Tissue sample removal from the cervix using LEEP during the scheduled colposcopy.


Estimated Enrollment: 80
Study Start Date: March 2005
Estimated Primary Completion Date: March 2009 (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
Tissue sample will be removed from the cervix. The LEEP is the standard of care treatment for the precancerous condition on your cervix.

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
Study Population

Patients with cervical cancer scheduled to be treated with the LEEP procedure.

Criteria

Inclusion Criteria:

  1. Patients who are 18 years of age or older.
  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:

  1. Patients who are younger than 18 years of age.
  2. Patients who are pregnant.
  3. Patients who are HIV positive.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00511615

Contacts
Contact: Michele Follen, MD, PhD 713-745-4780

Locations
United States, Texas
U.T.M.D. Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Principal Investigator: Michele Follen, MD, PhD            
UT Health Science Center-Houston Recruiting
Houston, Texas, United States, 77030
Lyndon B. Johnson Hospital Recruiting
Houston, Texas, United States, 77030
Canada, British Columbia
British Columbia Cancer Agency Recruiting
Vancouver, British Columbia, Canada
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Principal Investigator: Michele Follen, MD, PhD U.T.M.D. Anderson Cancer Center
  More Information

Responsible Party: U.T.M.D. Anderson Cancer Center ( Michele Follen, MD, PhD/Professor )
Study ID Numbers: 2004-0862
Study First Received: August 2, 2007
Last Updated: August 26, 2008
ClinicalTrials.gov Identifier: NCT00511615  
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

Study placed in the following topic categories:
Cervical intraepithelial neoplasia
Carcinoma in Situ
Neoplasms, Glandular and Epithelial
Carcinoma
Cervical Intraepithelial Neoplasia

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on January 16, 2009