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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

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Cervical Cancer

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Trial Information

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

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

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

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.

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Number of Patients with sentinel lymph nodes in the parametrium

Outcome Time Frame:

Determination during surgery (with intraoperative lymphatic mapping)

Safety Issue:


Principal Investigator

Michael M. Frumovitz, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

M.D. Anderson Cancer Center


United States: Institutional Review Board

Study ID:




Start Date:

February 2008

Completion Date:

Related Keywords:

  • Cervical Cancer
  • Cervical Cancer
  • Parametrial Lymph Nodes
  • Sentinel Nodes
  • Intraoperative Lymphatic Mapping
  • Single Photon Emission Computed Tomography
  • Uterine Cervical Neoplasms



UT MD Anderson Cancer Center Houston, Texas  77030