Brief Title
Hysteroscopic Lymphatic Mapping for Endometrial Cancer
Official Title
Hysteroscopic Injection of Tracers for Sentinel Node Identification in Women With Endometrial Cancer
Brief Summary
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.
Detailed Description
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.
Study Phase
Phase 2
Study Type
Interventional
Primary Outcome
Sentinel Node Identification Rate
Condition
Endometrial Cancer
Intervention
Intraoperative Lymphatic Mapping
Study Arms / Comparison Groups
Intraoperative Lymphatic Mapping
Description: Intraoperative sentinel lymph node identification (lymphatic mapping)
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
5
Start Date
April 2008
Completion Date
June 2010
Primary Completion Date
June 2010
Eligibility Criteria
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).
Gender
Female
Ages
N/A - N/A
Accepts Healthy Volunteers
No
Contacts
Michael M. Frumovitz, MD, ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT00671606
Organization ID
2007-0206
Responsible Party
Sponsor
Study Sponsor
M.D. Anderson Cancer Center
Study Sponsor
Michael M. Frumovitz, MD, Principal Investigator, M.D. Anderson Cancer Center
Verification Date
April 2012