Hysteroscopic Lymphatic Mapping for Endometrial Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00671606
Recruitment Status : Terminated (Slow accrual.)
First Posted : May 5, 2008
Results First Posted : July 27, 2011
Last Update Posted : May 27, 2016
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

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.

Condition or disease Intervention/treatment Phase
Endometrial Cancer Procedure: Intraoperative Lymphatic Mapping Phase 2

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 5 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Hysteroscopic Injection of Tracers for Sentinel Node Identification in Women With Endometrial Cancer
Study Start Date : April 2008
Actual Primary Completion Date : June 2010
Actual Study Completion Date : June 2010

Arm Intervention/treatment
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.

Primary Outcome Measures :
  1. Sentinel Node Identification Rate [ Time Frame: 15-20 minute procedure prior to/during routine surgery for identifying the sentinel nodes ]
    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.

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00671606

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

Additional Information:
Responsible Party: M.D. Anderson Cancer Center Identifier: NCT00671606     History of Changes
Other Study ID Numbers: 2007-0206
First Posted: May 5, 2008    Key Record Dates
Results First Posted: July 27, 2011
Last Update Posted: May 27, 2016
Last Verified: April 2012

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

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