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Hysteroscopic Injection of Tracers for Sentinel Node Identification in Women With Endometrial Cancer

Phase 2
Not Enrolling
Endometrial Cancer

Thank you

Trial Information

Hysteroscopic Injection of Tracers for Sentinel Node Identification in Women 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.

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

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

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).

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:

Sentinel Node Identification Rate

Outcome Description:

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.

Outcome Time Frame:

15-20 minute procedure prior to/during routine surgery for identifying the sentinel nodes

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:

April 2008

Completion Date:

June 2010

Related Keywords:

  • Endometrial Cancer
  • Endometrial Cancer
  • Lymphatic Mapping
  • Sentinel Node Identification
  • Lymph Node
  • Intraoperative lymphatic mapping
  • Total hysterectomy
  • Bilateral salpingooophorectomy
  • Lymph node staging
  • Laparotomy
  • Laparoscopy
  • Endometrial Neoplasms
  • Sarcoma, Endometrial Stromal
  • Adenoma



UT MD Anderson Cancer CenterHouston, Texas  77030
St. Luke's Episcopal HospitalHouston, Texas  77030