Analysis of Parametrial Lymph Nodes as Sentinel Nodes in Patients With Cervical Cancer
Analysis of Parametrial Lymph Nodes as Sentinel Nodes in Patients With Cervical Cancer
The goal of this clinical research study is to find out if the parametrial nodes are
 "sentinel" nodes (the lymph nodes believed to be the greatest risk for the spread of cancer)
 and if intraoperative lymphatic mapping can identify "sentinel" lymph nodes in the
 parametrium (the tissue that is on either side of the cervix). Identifying these lymph nodes
 may help to predict the status of the remaining lymph nodes in the pelvis. This research will
 also determine if India Ink is safe to use with the blue dye and radioactive tracer and if it
 improves the process of identifying the sentinel nodes.
Lymph nodes are glands that play an important part in your body's defense against infection.
 They are also the most common site of cancer spread in patients with cervical cancer.
 Intraoperative lymphatic mapping is a procedure that has been used in patients with other
 types of cancer to identify the "sentinel" lymph node. Researchers know that if the sentinel
 node does not contain cancer, then the remaining lymph nodes are almost always cancer-free.

 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.
Inclusion Criteria:

 1. Patients who are dispositioned to undergo radical hysterectomy or radical
 trachelectomy and pelvic lymphadenectomy.

 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:

 1. Patients with known allergies to triphenylmethane compounds or India ink.

 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.