A Prospective Investigation of the Use of Fluorescence Imaging on the da Vinci Surgical System for Ultrastaging of Endometrial Cancer by Sentinel Node Assessment
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 123
- 试验地点
- 6
- 主要终点
- Evaluating detection rate and accuracy of fluorescence-guided sentinel lymph node detection in endometrial cancer.
研究概览
简要总结
The main purpose of the study is to evaluate the detection rate and accuracy of fluorescence imaging in endometrial cancer staging by sentinel node assessment.
详细描述
In many cancer types, such as breast cancer and melanoma, sentinel node assessment has become the standard of care surgical treatment. Sentinel nodes are the first lymph nodes to which cancer cells are likely to spread from a primary tumor. Removal of a sentinel node for examination accurately predicts whether the cancer has spread to other nodes further along in the nodal chain. Fluorescence imaging with ICG dye (Indocyanine Green) has been used to detect lymph nodes in patients with gastric, colorectal and breast cancer. To date, the use of this technique in endometrial cancer has not been reported.
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
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Biopsy proven endometrial carcinoma
- •Must have planned to undergo standard endometrial cancer staging surgery as part of their routine clinical care
- •Must be 18 years of age and older
- •Must be able to comply with all the study procedures
排除标准
- •Significant liver disease, cirrhosis or liver insufficiency with abnormal liver function tests, with total bilirubin > 1.5 times normal, and/or SGOT > 2 times normal
- •Uremia, serum creatinine > 2.0 mg/dl
- •Previous history of adverse reaction or allergy to ICG dye, iodine, shellfish, or iodine dyes
- •Previous lymphadenectomy or surgery that could change the uterine lymphatic drainage
- •Currently participating in a drug, biologic and/or device treatment study
- •Any medical condition that would normally prevent someone from receiving general anesthesia or undergoing standard surgical procedures
结局指标
主要结局
Evaluating detection rate and accuracy of fluorescence-guided sentinel lymph node detection in endometrial cancer.
时间窗: Average expected time of 12 weeks
次要结局
- Determine the rate of upstaging using fluorescence-guided sentinel lymph node assessment by microscopic evaluation.(Average expected time of 12 weeks)