Analysis of Parametrial Lymph Nodes as Sentinel Nodes in Patients With Cervical Cancer
NCT ID: NCT00631241
Last Updated: 2016-05-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
20 participants
INTERVENTIONAL
2008-02-29
2012-09-30
Brief Summary
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Detailed Description
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Researchers believe that the parametrial lymph nodes (1 group of lymph nodes located in the parametrium) are the sentinel lymph nodes in patients with cervical cancer. Surgical removal of the parametrial lymph nodes is currently the only known way to accurately find out whether or not these lymph nodes have cancer in them.
Stage IA2 or IB1 cervix cancer is treated by a radical hysterectomy (removal of the uterus, cervix, and the parametrium) or radical trachelectomy (removal of the cervix and the parametrium). Pelvic lymph nodes and possibly para-aortic lymph nodes (near the aorta in the abdomen) are also removed. This procedure is called a pelvic and para-aortic lymphadenectomy.
If you agree to take part in this study, you will undergo a procedure called intraoperative lymphatic mapping. This procedure is done in the operating room. When you are asleep (under anesthesia), the surgeon will inject the cervix with a very small amount (less than one tenth of a teaspoon) of a radioactive material in 4 different places around the edge of the tumor in the cervix. This injection is given over 1-2 minutes. The cervix is then injected with 2 different blue dyes called Isosulfan Blue and India ink (about 1 1/2 teaspoons). These injections take less than 5 minutes. The surgeon will then use a special hand-held instrument for measuring radioactivity to help find the sentinel lymph nodes before and after the operation begins. During the operation, the surgeon will also visually inspect the lymph nodes to see if they are blue (stained by the blue dye and India Ink). These 2 techniques (the radioactive material and the dye and ink) will help the surgeon identify the sentinel nodes by their blue color and their level of radioactivity.
During your hospitalization or at your first clinic visit, your doctor will tell you whether or not cancer was found in the lymph nodes that were removed during surgery.
You will be taken off study if intolerable side effects occur. You will be considered off study after your first doctor's visit after the surgery.
This is an investigational study. Up to 20 patients will take part in this study. All will be enrolled at M. D. Anderson.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Intraoperative Lymphatic Mapping
Single Photon Emission Computed Tomography - First 3 Patients = Performed 30-45 minutes, 2-3 hours, and 20-24 hours after injections of the radioactive material or just before surgery; Remaining 17 Patients = Performed only one at a time as was found to be best based on the scans from first 3 patients. Isosulfan Blue and India ink will be injected into the cervix to help the surgeon identify the sentinel nodes by their blue color and their level of radioactivity.
Single Photon Emission Computed Tomography
First 3 Patients = Performed 30-45 minutes, 2-3 hours, and 20-24 hours after injections of the radioactive material or just before surgery; Remaining 17 Patients = Performed only one at a time as was found to be best based on the scans from first 3 patients.
Intraoperative Lymphatic Mapping
Isosulfan Blue and India ink will be injected into the cervix to help the surgeon identify the sentinel nodes by their blue color and their level of radioactivity.
Interventions
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Single Photon Emission Computed Tomography
First 3 Patients = Performed 30-45 minutes, 2-3 hours, and 20-24 hours after injections of the radioactive material or just before surgery; Remaining 17 Patients = Performed only one at a time as was found to be best based on the scans from first 3 patients.
Intraoperative Lymphatic Mapping
Isosulfan Blue and India ink will be injected into the cervix to help the surgeon identify the sentinel nodes by their blue color and their level of radioactivity.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. No evidence of metastases on computed tomography, magnetic resonance imaging, or PET/CT scan.
3. Patients must be good surgical candidates.
4. Patients who have signed an approved informed consent and authorization permitting release of personal health information.
5. For patients of child-bearing age, a negative serum pregnancy test within 72 hours prior to injection of radiocolloid. Child-bearing potential is defined as not post-menopausal for 12 months or no previous surgical sterilization.
Exclusion Criteria
2. Patients with a history of retroperitoneal surgery.
3. Patients with a history of pelvic irradiation.
4. Patients who had a cold knife or LEEP cone biopsy within 4 weeks of enrollment.
FEMALE
No
Sponsors
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M.D. Anderson Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Michael M. Frumovitz, MD
Role: PRINCIPAL_INVESTIGATOR
M.D. Anderson Cancer Center
Locations
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UT MD Anderson Cancer Center
Houston, Texas, United States
Countries
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Related Links
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UT MD Anderson Cancer Center Website
Other Identifiers
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2006-0153
Identifier Type: -
Identifier Source: org_study_id
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