Hysteroscopic Injection of Tracers for Sentinel Node Identification in Women With Endometrial Cancer
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 5
- 试验地点
- 4
- 主要终点
- Sentinel Node Identification Rate
研究概览
简要总结
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.
详细描述
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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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).
结局指标
主要结局
Sentinel Node Identification Rate
时间窗: 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.
次要结局
未报告次要终点