Comparison of Superficial-Only Versus Combined Indocyanine Green Injection Techniques for Sentinel Lymph Node Mapping in Patients With Endometrial Cancer (FLARES)
Comparison of Superficial-Only Versus Combined Indocyanine Green Injection Techniques for Sentinel Lymph Node Mapping in Patients With Endometrial Cancer: A Randomized Clinical Trial
This Clinical trial will compare ICG cervical superficial injections versus superficial and deep injection for sentinel lymph node mapping in early-stage endometrial cancer patients
研究概览
地位
条件
详细说明
This study will compare indocyanine green cervical injection superficial versus superficial and deep injection for sentinel lymph node mapping in early-stage endometrial cancer patients
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名：Luis Pires Melo Filho, Dr
- 电话号码：7126 1733216600
- 邮箱：luisfilho4@hotmail.com
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Women aged ≥18 years with a confirmed diagnosis of stage I endometrial cancer who underwent sentinel lymph node mapping with ICG at Barretos Cancer Hospital Treated using a minimally invasive approach (laparoscopic or robotic).
Exclusion Criteria:
- Allergic reaction of ICG and Iodo
- Previous gynecologic oncology disease
- Previous pelvic radiotherapy
学习计划
研究是如何设计的？
设计细节
- 主要用途：诊断
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Superficial cervical ICG injection
Superficial cervical ICG injection for sentinel lymph node mapping |
Superficial ICG cervical injections
其他名称：
|
|
有源比较器：Deep and superficial ICG cervical injection
Deep and superficial ICG cervical injection |
Deep and superficial ICG cervical injection for sentinel lymph node mapping |
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Rate of pelvic bilateral sentinel lymph detection with superficial ICG cervical injection compared to deep and superficial cervical injection
大体时间：12 weeks
|
Our primary objective will be to compare the bilateral pelvic sentinel lymph node detection rates between superficial cervical injection of ICG and combined deep and superficial cervical injection. |
12 weeks
|
|
Noninferiority of superficial ICG cervical injection for sentinel lymph node detection
大体时间：From enrollment to the end of treatment at 12 weeks
|
The noninferiority of superficial cervical ICG injection compared with combined deep and superficial cervical injection for sentinel lymph node detection will be evaluated. |
From enrollment to the end of treatment at 12 weeks
|
合作者和调查者
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.