Hysteroscopic Lymphatic Mapping for Endometrial Cancer

This study has been terminated.
(Slow accrual.)
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00671606
First received: April 29, 2008
Last updated: April 16, 2012
Last verified: April 2012

April 29, 2008
April 16, 2012
April 2008
June 2010   (final data collection date for primary outcome measure)
Sentinel Node Identification Rate [ Time Frame: 15-20 minute procedure prior to/during routine surgery for identifying the sentinel nodes ] [ Designated as safety issue: No ]
Feasibility of sentinel node identification rate using intraoperative hysteroscopic injection of patent blue dye and radiocolloid for the detection of sentinel lymph nodes in patients with endometrial cancer. Sentinel node identification before and during surgery using a gamma counter to identify lymph nodes that have absorbed Tc-99m sulfur colloid. Study feasibility assessed with enrollment of 20 participants, approximately 1 year.
The goal of this clinical research study is to learn if a procedure called intraoperative (during surgery) lymphatic mapping can be used to find the sentinel lymph node in patients with endometrial cancer. [ Time Frame: 1 Year ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00671606 on ClinicalTrials.gov Archive Site
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Hysteroscopic Lymphatic Mapping for Endometrial Cancer
Hysteroscopic Injection of Tracers for Sentinel Node Identification in Women With Endometrial Cancer

The goal of this clinical research study is to learn if a procedure called intraoperative (during surgery) lymphatic mapping can be used to find the sentinel lymph node in patients with endometrial cancer.

Experimental Procedures:

Lymph nodes are oval-shaped glands where immune reactions occur. For patients with endometrial cancer, lymph node status is an important factor for planning the cancer treatment course and predicting the status of the cancer. The "sentinel" node is the lymph node closest to the main tumor area, and it is 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 usually cancer-free.

In this study, researchers want to study possibly using lymphatic mapping in future patients as an alternative to completely removing the lymph nodes in the pelvis (hip area) and para-aortic (upper abdomen) area.

Intraoperative sentinel lymph node identification (lymphatic mapping) uses 2 techniques. The first technique involves injecting a small amount of weak radioactive material, and the second involves injecting a drug called isosulfan blue or methylene blue. These techniques are being studied to see if the surgeon can locate ("map") lymph nodes that may contain tumor cells.

Routine Surgical Treatment:

As part of routine care, all participants in this study will have surgery to remove the uterus, cervix, 1-2 inches of the vagina, fallopian tubes, ovaries, and the lymph nodes in 2 areas of the waist.

Study Procedures:

If you agree to take part in this study, after you have been given the anesthetic for your surgery, your uterus will be examined to locate the tumor(s). After the tumor(s) are located, they will be injected with a radioactive substance called Tc-99m sulfur colloid. The tumors will then be injected with a dye called isosulfan blue or methylene blue, which is used to turn the sentinel node blue.

Before and during your surgery, a gamma counter (a special hand-held instrument that measures radioactivity) will be used to identify lymph nodes that have absorbed the Tc-99m sulfur colloid. The surgeon will also be able to see the lymph nodes that have absorbed the blue dye.

Information Collection:

In addition to the study procedures, researchers will collect clinical information about you that will be compared with the study results. This information includes your date of birth, age, race, height, weight, number of any past pregnancies and deliveries, any other medical conditions, and any earlier surgeries. It also includes the date of the cancer diagnosis, the status of the cancer diagnosis before surgery, the status of the disease, and the results of routine scans before surgery (chest x-ray and computed tomography [CT] or magnetic resonance imaging [MRI] scan, if performed).

Length of Study Participation:

Your participation in this study will be over after the 15-20 minute procedure for identifying the sentinel nodes. The routine surgery will occur after that, which can take up to 5 hours.

This is an investigational study. Tc-99m sulfur colloid, the blue dye (either isosulfan blue or methylene blue), and the gamma counter are FDA approved for the procedures used in this study.

Performing lymph node mapping and sentinel node identification during surgery in patients with endometrial cancer is considered experimental.

Up to 20 women will take part in this multicenter study. Up to 10 will be enrolled at M. D. Anderson.

Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Endometrial Cancer
Procedure: Intraoperative Lymphatic Mapping
Intraoperative hysteroscopic injection of patent blue dye and radiocolloid for detection of sentinel lymph nodes.
Experimental: Intraoperative Lymphatic Mapping
Intraoperative sentinel lymph node identification (lymphatic mapping)
Intervention: Procedure: Intraoperative Lymphatic Mapping
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
5
June 2010
June 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Patients with biopsy confirmed endometrial cancer who have been dispositioned to undergo total hysterectomy, bilateral salpingooophorectomy and lymph node staging.
  2. Surgical procedures may be performed by either laparotomy or laparoscopy.
  3. If computed tomography, magnetic resonance imaging, lymphangiography, or ultrasound has been performed for preoperative assessment, there must be no evidence of metastases. Imaging is not mandatory.
  4. Patients who have signed an approved informed consent and authorization permitting release of personal health information.

Exclusion Criteria:

  1. Patients with a preoperative diagnosis of grade I endometrioid adenocarcinoma of the uterus.
  2. Patients with uterine papillary serous carcinoma.
  3. Patients who have undergone endometrial ablation or a myomectomy within 1 year of the surgery for endometrial cancer.
  4. Patients with known allergies to triphenylmethane compounds or technetium-99 radiocolloid.
  5. Patients with a history of retroperitoneal surgery.
  6. Patients with a history of pelvic radiation.
  7. Patients with no lesion visible on hysteroscopy.
  8. Patients with previous exposure to the tracer (to prevent risk of allergic reaction).
Female
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No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00671606
2007-0206
No
M.D. Anderson Cancer Center
M.D. Anderson Cancer Center
Not Provided
Principal Investigator: Michael M. Frumovitz, MD M.D. Anderson Cancer Center
M.D. Anderson Cancer Center
April 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP