Feasibility Study to Develop Sentinel Lymph Node Mapping in Rectal Cancer Patients
Novel Sentinel Lymph Node Mapping Technique in Early Stage Rectal Cancer
The purpose of this study is to see if investigators can develop a technique to identify sentinel lymph nodes in the rectum for rectal cancer patients with the use of a radiotracer (Tc-sulfur colloid), a dye (Spot), and imaging, both pre- and intraoperatively. Eligible patients are those with stage I-III rectal cancer undergoing standard low anterior resection or abdominoperineal resection.
Investigators hypothesize that use of a unique intraoperative lymphatic mapping technique using a mobile gamma camera will identify the sentinel lymph node in patients with rectal cancer with greater than 80% sensitivity.
Subjects will receive injections of the tracer and dye prior to surgery, have preoperative SPECT/CT imaging to be used as a guide to the rectal lymphatic system and then proceed to their scheduled surgery. During surgery, images of the rectum will be taken with a unique mobile gamma camera prior to removal and upon resection.
If surgeons are able to identify the sentinel lymph nodes surrounding the rectal tumor, the hope is to combine this technique with a less invasive surgery called transanal endoscopic microsurgery (TEM) for early stage rectal cancer patients.
研究概览
地位
条件
研究类型
阶段
- 不适用
联系人和位置
学习地点
-
-
Virginia
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Charlottesville、Virginia、美国、22908
- University of Virginia
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-
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:
- Adult patients with stage I,II, or III rectal cancer undergoing standard trans- abdominal low anterior resection or abdominoperineal resection surgery at the University of Virginia
- Willing and able to give written informed consent
Exclusion Criteria:
- Patients less than 18 years of age
- Women who are pregnant and/or breastfeeding
- Prisoners
- Unable to give written informed consent
- Participants with medical contradictions or have potential problems complying with the requirements of the protocol, in the opinion of the investigator
学习计划
研究是如何设计的？
设计细节
- 主要用途：诊断
- 分配：不适用
- 介入模型：单组作业
- 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：Surgery with pre- and intra-op imaging
Subjects will have a preoperative flexible sigmoidoscopy where they will receive an endoscopic injection of 99mTc-sulfur colloid (up to 0.5 mCi) and 3 to 5 cc of circumferential endoscopic injections of Spot.
A SPECT/CT will be performed prior to surgery to identify lymph nodes in the rectum.
Subjects will proceed to their standard surgery.
Intraoperative mobile gamma camera imaging of the rectum will occur before and after resection in attempt to identify sentinel lymph nodes.
|
Intraoperative images will be taken with a unique mobile gamma camera to identify sentinel lymph nodes in the rectum.
Radiotracer injection around the rectal tumor for pre- and intra-operative imaging.
其他名称：
Dye injection for tattooing rectal tumor prior to surgical resection.
Flexible sigmoidoscopy prior to surgery to facilitate endoscopic injections of radiotracer and dye.
Preoperative imaging to identify lymph nodes in rectum.
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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 |
|---|---|---|
|
Evaluating the sensitivity of identifying the sentinel lymph node using a unique mobile gamma camera intraoperatively.
大体时间：At the time of surgery and the time of pathological review, an expected average of 7 days.
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The primary endpoint is the sensitivity of sentinel lymph node (SLN) detection by the technique which will be estimated by the number of SLNs detected by the technique divided by the number noted at surgery or on final pathology review.
90% confidences interval around the estimate will help guide interpretation of the results.
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At the time of surgery and the time of pathological review, an expected average of 7 days.
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Feasibility
大体时间：From the time of tracer and dye injections to 30 day postoperative visit
|
Descriptive summaries will be used to list any complications that may have occurred pre-, intra- or post-operatively.
Frequency and location of the sentinel lymph node (SLN) with respect to the tumor prior to surgery will be noted.
In addition the location of the SLN in relation to the tumor will be documented during pathologic examination with the pathologist and surgeon to assess the feasibility of excision with transanal endoscopic microsurgery.
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From the time of tracer and dye injections to 30 day postoperative visit
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合作者和调查者
调查人员
- 首席研究员：Traci L Hedrick, MD、University of Virginia
研究记录日期
研究主要日期
学习开始
初级完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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