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
  Purpose

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.


Condition Intervention Phase
Endometrial Cancer
Procedure: Intraoperative Lymphatic Mapping
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Hysteroscopic Injection of Tracers for Sentinel Node Identification in Women With Endometrial Cancer

Resource links provided by NLM:


Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • 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.


Enrollment: 5
Study Start Date: April 2008
Study Completion Date: June 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Intraoperative Lymphatic Mapping
Intraoperative sentinel lymph node identification (lymphatic mapping)
Procedure: Intraoperative Lymphatic Mapping
Intraoperative hysteroscopic injection of patent blue dye and radiocolloid for detection of sentinel lymph nodes.

  Hide Detailed Description

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.

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00671606

Locations
United States, Texas
UT MD Anderson Cancer Center
Houston, Texas, United States, 77030
St. Luke's Episcopal Hospital
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Principal Investigator: Michael M. Frumovitz, MD M.D. Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00671606     History of Changes
Other Study ID Numbers: 2007-0206
Study First Received: April 29, 2008
Results First Received: June 30, 2011
Last Updated: April 16, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:
Endometrial Cancer
Lymphatic Mapping
Sentinel Node Identification
Lymph Node
Intraoperative lymphatic mapping
Total hysterectomy
Bilateral salpingooophorectomy
Lymph node staging
Laparotomy
Laparoscopy

Additional relevant MeSH terms:
Endometrial Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Diseases
Genital Diseases, Female

ClinicalTrials.gov processed this record on August 28, 2014