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Molecular Imaging for Detection of Cervical Intraepithelial Neoplasia

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00511615
First received: August 2, 2007
Last updated: July 31, 2012
Last verified: July 2012
  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 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.

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

Resource links provided by NLM:


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

Primary Outcome Measures:
  • 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
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00511615

Locations
United States, Texas
Lyndon B. Johnson Hospital
Houston, Texas, United States, 77030
U.T.M.D. Anderson Cancer Center
Houston, Texas, United States, 77030
UT Health Science Center-Houston
Houston, Texas, United States, 77030
Canada, British Columbia
British Columbia Cancer Agency
Vancouver, British Columbia, Canada
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
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:
Carcinoma in Situ
Cervical Intraepithelial Neoplasia
Uterine Cervical Neoplasms
Carcinoma
Genital Diseases, Female
Genital Neoplasms, Female
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial
Urogenital Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Uterine Neoplasms

ClinicalTrials.gov processed this record on November 20, 2014