Hysteroscopic Lymphatic Mapping for Endometrial Cancer
This study has been terminated.
(Slow accrual.)
Sponsor:
M.D. Anderson Cancer Center
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
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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.
|
Show Detailed Description 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 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).
Contacts and Locations
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 Sarcoma, Endometrial Stromal Adenoma Uterine Neoplasms Genital Neoplasms, Female Urogenital Neoplasms Neoplasms by Site Neoplasms |
Uterine Diseases Genital Diseases, Female Neoplasms, Complex and Mixed Neoplasms by Histologic Type Sarcoma Neoplasms, Connective and Soft Tissue Endometrial Stromal Tumors Neoplasms, Glandular and Epithelial |
ClinicalTrials.gov processed this record on May 19, 2013