Analysis of Parametrial Lymph Nodes as Sentinel Nodes in Patients With Cervical Cancer
Procedure: Single Photon Emission Computed Tomography
Procedure: Intraoperative Lymphatic Mapping
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Histopathologic Analysis of Parametrial Lymph Nodes as Sentinel Nodes in Patients With Cervical Cancer Undergoing Radical Hysterectomy or Radical Trachelectomy and Pelvic Lymph Node Dissection: A Feasibility Study|
- Number of Patients with sentinel lymph nodes in the parametrium [ Time Frame: Determination during surgery (with intraoperative lymphatic mapping) ] [ Designated as safety issue: No ]
Sentinel nodes classified according to modification of American Joint Committee on Cancer (AJCC) staging for axillary nodes from breast cancer as follows: 1) metastases present - tumor > 2.0 mm in diameter; 2) micrometastases present - tumor cell aggregates between 0.2 and 2.0 mm in diameter; 3) isolated tumor cells - individual tumor cells or aggregates <0.2 mm in diameter, usually detected by immunohistochemistry; or 4) tumor absent - no tumor cells identified in H&E (or immunohistochemically) stained sections.
Parametrium separated from cervix/uterus by pathology then away from primary cervical lesion will be re-examined for sentinel nodes both visually & with handheld gamma counter; & all parametrial tissue will be submitted for pathologic sectioning to detect carbon particles in parametrial sentinel nodes not detected by gamma counter or direct visualization.
|Study Start Date:||February 2008|
|Study Completion Date:||September 2012|
|Primary Completion Date:||September 2012 (Final data collection date for primary outcome measure)|
Experimental: 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.
Procedure: 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.
Other Name: SPECT/CTProcedure: 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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00631241
|United States, Texas|
|UT MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Michael M. Frumovitz, MD||M.D. Anderson Cancer Center|