Lymphoscintigraphy in Patients With Vaginal Cancer

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Brief Title

Lymphoscintigraphy in Patients With Vaginal Cancer

Official Title

Lymphoscintigraphy and Selective Lymphatic Mapping in Patients With Invasive Vaginal Cancer

Brief Summary

      Primary Objectives:

        1. Determine the feasibility of using pretreatment lymphoscintigraphy to identify the
           sentinel lymph node(s) in patients with vaginal cancer dispositioned to receive
           radiation therapy.

        2. Determine the feasibility of using preoperative lymphoscintigraphy and intraoperative
           lymphatic mapping to identify the sentinel lymph node(s) in patients with vaginal cancer
           dispositioned to undergo surgery and bilateral lymph node dissection.
    

Detailed Description

      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.
    


Study Type

Interventional


Primary Outcome

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


Condition

Vaginal Cancer

Intervention

Lymphoscintigraphy

Study Arms / Comparison Groups

 Lymphoscintigraphy
Description:  

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Procedure

Estimated Enrollment

14

Start Date

September 2002

Completion Date

May 2008

Primary Completion Date

May 2008

Eligibility Criteria

        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.
      

Gender

Female

Ages

N/A - N/A

Accepts Healthy Volunteers

No

Contacts

Charles Levenback, MD, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT00528034

Organization ID

ID02-239


Responsible Party

Sponsor

Study Sponsor

M.D. Anderson Cancer Center


Study Sponsor

Charles Levenback, MD, Principal Investigator, M.D. Anderson Cancer Center


Verification Date

July 2012