Detection of Sentinel Lymph Nodes in Patients With Endometrial Cancer Undergoing Robotic-Assisted Staging: Comparison of Isosulfan Blue and Indocyanine Green Dyes With Fluorescence Imaging
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 204
- 试验地点
- 2
- 主要终点
- Negative Predictive Value of Sentinel Lymph Node Prediction of Metastatic Disease
研究概览
简要总结
This clinical trial studies lymph node mapping in patients with endometrial cancer. Lymph node mapping may allow for limited removal of lymph nodes in as part of endometrial cancer staging and treatment.
详细描述
PRIMARY OBJECTIVE:
I. To estimate the negative predictive value of pelvic sentinel lymph node (SLN) in endometrial cancer to predict nodal metastasis.
SECONDARY OBJECTIVE:
II. To examine the ability of sentinel lymph nodes to increase the detection of metastatic disease through ultra-sectioning and immuno-histochemical (IHC) staining by comparing IHC results and standard hematoxylin and eosin (H&E) results.
OUTLINE:
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 85 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •The patient must be willing and able to provide informed consent
- •The patient is willing and able to comply with the study protocol
- •The patient has endometrial cancer and is scheduled for robotic hysterectomy and lymphadenectomy
- •The patient agrees to follow-up examinations out to 5-years post-treatment
排除标准
- •The patient is not a candidate for robotic assisted hysterectomy and lymphadenectomy
- •The patient has known or suspected allergies to iodine, indocyanine green (ICG) or isosulfan blue (ISB)
- •The patient has hepatic dysfunction confirmed by bilirubin > 2 x normal (based on reference values from the laboratory used by the patient)
研究组 & 干预措施
sentinel lymph node detection
Patients undergo sentinel lymph node detection using fluorescence imaging with indocyanine green solution and isosulfan blue and sentinel lymph node biopsy.
干预措施: sentinel lymph node detection (Procedure)
sentinel lymph node detection
Patients undergo sentinel lymph node detection using fluorescence imaging with indocyanine green solution and isosulfan blue and sentinel lymph node biopsy.
干预措施: indocyanine green solution (Drug)
sentinel lymph node detection
Patients undergo sentinel lymph node detection using fluorescence imaging with indocyanine green solution and isosulfan blue and sentinel lymph node biopsy.
干预措施: isosulfan blue (Drug)
sentinel lymph node detection
Patients undergo sentinel lymph node detection using fluorescence imaging with indocyanine green solution and isosulfan blue and sentinel lymph node biopsy.
干预措施: sentinel lymph node biopsy (Procedure)
结局指标
主要结局
Negative Predictive Value of Sentinel Lymph Node Prediction of Metastatic Disease
时间窗: average of 1-14 days after the procedure when final pathologic evaluation has been completed
NPV is found by dividing the number of true negatives by the number of all patients without pelvic lymph node metastases. Exact 95% confidence intervals (CIs) for the proportions will be calculated.
次要结局
- Percentage of Metastatic Cases Found Using Ultra-sectioning and IHC Staining(average of 1-14 days after the procedure when final pathologic evalulation has been completed)
研究者
Floor Backes
Principal Investigator
Ohio State University Comprehensive Cancer Center