Cervical CancerNCT00511615
Molecular Imaging for Detection of Cervical Intraepithelial Neoplasia
An observational study of Cervical Cancer, run by M.D. Anderson Cancer Center at 4 sites in 2 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Cervical Cancer
- What is being tested?
- Loop Electrosurgical Excision Procedure (LEEP)
- Type of treatment
- Surgery or procedure
- How many people
- 30 participants
- Where
- 4 sitesin 2 countries
- Study dates
- Mar 2005to Feb 2008
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Patients with cervical cancer scheduled to be treated with the LEEP procedure.
Who may be able to join
- 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.
Who cannot join
- Patients who are younger than 18 years of age.
- Patients who are pregnant.
- Patients who are HIV positive.
Trial locations and contacts
4 sites in 2 countries.
4 sites in 2 countries
United States3 sites
Lyndon B. Johnson Hospital
Houston, Texas, 77030
U.T.M.D. Anderson Cancer Center
Houston, Texas, 77030
UT Health Science Center-Houston
Houston, Texas, 77030
About this study
Official title: A Feasibility Study of Molecular Imaging for Detection of Cervical Intraepithelial Neoplasia
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.
Read the 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.
- Conditions
- Cervical Cancer
- Being tested
- Loop Electrosurgical Excision Procedure (LEEP)
- Keywords
- Cervical Intraepithelial Neoplasia, Loop Electrosurgical Excision Procedure, Cervical Cancer, Colposcopy, Molecular Imaging, LEEP
- Medical subject headings
- Uterine Cervical Neoplasms, Uterine Cervical Dysplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Loop Electrosurgical Excision Procedure (LEEP)Procedure or surgery
Also called LEEP
Tissue sample removed from cervix using LEEP and contrast agent.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Patients with cervical cancer scheduled to be treated with the LEEP procedure. Receives: Procedure: Loop Electrosurgical Excision Procedure (LEEP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2007 (estimated)
- Study startMar 2005
- Primary completionFeb 2008
- Study completionFeb 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cervical CancerStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Michele Follen, MD, PhD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00511615
- Sponsor's protocol ID
- 2004-0862
- Status last verified
- Jul 2012
- First submitted
- 2 Aug 2007
- Last updated
- 1 Aug 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 17614715
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Feasibility Study of Molecular Imaging for Detection of Cervical Intraepithelial Neoplasia
- ClinicalTrials.gov ID
- NCT00511615
- Acronym / sponsor ID
- 2004-0862
- Conditions
- Cervical Cancer
- Keywords
- Cervical Intraepithelial Neoplasia, Loop Electrosurgical Excision Procedure, Cervical Cancer, Colposcopy, Molecular Imaging, LEEP
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Mar 2005
- Primary completion
- Feb 2008 (actual)
- Study completion
- Feb 2008 (actual)
- First posted
- 6 Aug 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Procedure: Loop Electrosurgical Excision Procedure (LEEP)Patients with cervical cancer scheduled to be treated with the LEEP procedure. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with cervical cancer scheduled to be treated with the LEEP procedure.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- Patients who are younger than 18 years of age.
- Patients who are pregnant.
- Patients who are HIV positive.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Loop Electrosurgical Excision Procedure (LEEP)Also: LEEPTissue sample removed from cervix using LEEP and contrast agent. | Procedure or surgery | 1 |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2012.
- Background: PubMed 17614715Aaron 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.
- UT MD Anderson Cancer Center WebsiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michele Follen, MD, PhD principal investigator
M.D. Anderson Cancer Center
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cervical Cancer, run by M.D. Anderson Cancer Center at 4 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00511615, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2012.