Hysteroscopic Lymphatic Mapping for Endometrial Cancer - Full Text View

Purpose

Primary Objective:

1. To examine the feasibility and sentinel node identification rate of intraoperative hysteroscopic injection of patent blue dye and radiocolloid for the detection of sentinel lymph nodes in patients with endometrial cancer.

Secondary Objectives:

To map the location(s) of sentinel node(s) draining primary endometrial cancer lesions.
To determine negative predictive value and false-negative rate for intraoperative hysteroscopic injection of patent blue dye and radiocolloid for the detection of sentinel lymph nodes in patients with endometrial cancer.

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

MedlinePlus related topics:

Cancer

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Diagnostic, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

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

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

Primary Outcome Measures:

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 ]

Estimated Enrollment:	20
Study Start Date:	April 2008
Estimated Primary Completion Date:	April 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Intraoperative Lymphatic Mapping	Procedure: Intraoperative Lymphatic Mapping Lymphatic mapping procedure performed during surgery.

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Eligibility

Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patients with biopsy confirmed endometrial cancer who have been dispositioned to undergo total hysterectomy, bilateral salpingooophorectomy and lymph node staging.
Surgical procedures may be performed by either laparotomy or laparoscopy.
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.
Patients who have signed an approved informed consent and authorization permitting release of personal health information.

Exclusion Criteria:

Patients with a preoperative diagnosis of grade I endometrioid adenocarcinoma of the uterus.
Patients with uterine papillary serous carcinoma.
Patients who have undergone endometrial ablation or a myomectomy within 1 year of the surgery for endometrial cancer.
Patients with known allergies to triphenylmethane compounds or techniciun-99 radiocolloid.
Patients with a history of retroperitoneal surgery.
Patients with a history of pelvic radiation.
Patients with no lesion visible on hysteroscopy.
Patients with previous exposure to the tracer (to prevent risk of allergic reaction).

Contacts and Locations

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

Contacts


Contact: Taren Johnston, RN	713-792-6828

Locations


United States, Texas
	U.T.M.D. Anderson Cancer Center	Recruiting
	Houston, Texas, United States, 77030
	Principal Investigator: Michael M. Frumovitz, MD
	St. Luke's Episcopal Hospital	Not yet recruiting
	Houston, Texas, United States, 77030

Sponsors and Collaborators

M.D. Anderson Cancer Center

Investigators


Principal Investigator:	Michael M. Frumovitz, MD	U.T.M.D. Anderson Cancer Center

More Information

Responsible Party:	U.T.M.D. Anderson Cancer Center ( Michael M. Frumovitz, MD/Assistant Professor )
Study ID Numbers:	2007-0206
First Received:	April 29, 2008
Last Updated:	April 29, 2008
ClinicalTrials.gov Identifier:	NCT00671606
Health Authority:	United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:

Endometrial Cancer

Lymphatic Mapping

Sentinel Node Identification

Lymph Node

Study placed in the following topic categories:

Genital Diseases, Female

Endometrial Neoplasms

Genital Neoplasms, Female

Uterine Diseases

Uterine Neoplasms

Urogenital Neoplasms

Endometrial cancer

Additional relevant MeSH terms:

Neoplasms

Neoplasms by Site

ClinicalTrials.gov processed this record on October 10, 2008

Sponsored by:	M.D. Anderson Cancer Center
Information provided by:	M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:	NCT00671606