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Lymphoscintigraphy and Selective Lymphatic Mapping in Patients With Invasive Vaginal Cancer

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Vaginal Cancer

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Trial Information

Lymphoscintigraphy and Selective Lymphatic Mapping in Patients With Invasive Vaginal Cancer

The treatment of vaginal cancer is usually surgical removal of the vaginal tumor with
removal of lymph nodes in the groin and/or pelvis. Patients who are not eligible to receive
surgery usually receive radiation therapy.

Lymph nodes are a common site for the spread of vaginal cancer. Lymphatic mapping has been
used in patients with other types of cancer to identify the "sentinel" lymph node. The
sentinel lymph node is the lymph node believed to be at greatest risk for spread of the
cancer. If the sentinel node does not contain cancer cells, then the remaining lymph nodes
are almost always cancer free.

This research study will find out if the sentinel node concept can be applied to patients
with vaginal cancer. The sentinel lymph node will be identified using a scan called
"lymphoscintigraphy". A very small amount (less than one tenth of a teaspoon) of a
radioactive material is injected around the edge of the tumor in the vagina, followed
immediately by the scan. The scan is done in the Nuclear Medicine Department of M. D.
Anderson before the patient has surgery or begins radiation therapy.

The dose of radiation injected into the vagina is much less than the dose received from a
chest x-ray and therefore there are no special precautions needed after the injection. If
the treatment plan is surgery, a second injection of the radioactive material may be
necessary on the day of the operation because the radiation fades quickly. Patients who
receive radiation therapy will not need a second injection. The radiation oncologist might
use the information collected from the scan to help with treatment planning.

For patients having surgery, a special hand held instrument that measures radioactivity
(similar to a Geiger counter) is used to help identify the location of the sentinel lymph
node before and after the operation begins. Blue dye is also used to find the sentinel node.
This requires the injection of up to a teaspoon of material called Isosulfan Blue around the
tumor in the vagina. This is done while the patient is under anesthesia. The surgeon can
then identify the sentinel node by its color (blue) and by its level of radioactivity (using
the gamma counter).

Patients will be notified of the results of the mapping and lymphoscintigraphy during their
hospitalization or their first clinic visit, depending on whether or not they had surgery.

This is an investigational study. Eighteen patients will take part in this study. All will
be enrolled at M. D. Anderson.

Inclusion Criteria:

- Patients must have invasive vaginal cancer, any histology, any stage.

- Patients with prior excision of the primary are eligible.

- Patients with recurrent vaginal cancer who have not had a prior inguinal or groin
lymph node dissection.

- Patients undergoing either surgical resection and assessment of inguinal or groin
lymph nodes, radiation therapy and/or chemotherapy.

- Patients must sign an IRB approved informed consent.

Exclusion Criteria:

- Known allergy to triphenylmethane compounds.

- Pregnancy.

- Prior radiation therapy to the vagina, vulva, groin or pelvis.

- Prior inguinal, femoral or pelvic lymphadenectomy.

- Patients who are not good surgical candidates.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

Identification of sentinel lymph node(s) in patients with vaginal cancer using lymphoscintigraphy and intraoperative lymphatic mapping.

Outcome Time Frame:

Preoperative and intraoperative, prior to radiation therapy, data collection

Safety Issue:


Principal Investigator

Charles Levenback, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

M.D. Anderson Cancer Center


United States: Institutional Review Board

Study ID:




Start Date:

September 2002

Completion Date:

May 2008

Related Keywords:

  • Vaginal Cancer
  • Vaginal Cancer
  • Lymphoscintigraphy
  • Lymphatic Mapping
  • Sentinel Lymph Node
  • Isosulfan Blue
  • Lymph
  • Vaginal Neoplasms



U.T.M.D. Anderson Cancer Center Houston, Texas  77030