Status:
TERMINATED
Hysteroscopic Lymphatic Mapping for Endometrial Cancer
Lead Sponsor:
M.D. Anderson Cancer Center
Conditions:
Endometrial Cancer
Eligibility:
FEMALE
Phase:
PHASE2
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 ca...
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 treatm...
Eligibility Criteria
Inclusion
- 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
- 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 technetium-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).
Key Trial Info
Start Date :
April 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2010
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT00671606
Start Date
April 1 2008
End Date
June 1 2010
Last Update
May 27 2016
Active Locations (2)
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1
St. Luke's Episcopal Hospital
Houston, Texas, United States, 77030
2
UT MD Anderson Cancer Center
Houston, Texas, United States, 77030