Prospective, Open-Label, Ex Vivo Comparison Study of Lymphoseek® and Vital Blue Dye (VBD) as Lymphoid Tissue Targeting Agents in Colon Cancer(CNC) Patients' Excised Colon w/ Abdominal Lymphatic Bed
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Efficacy of Lymphoseek for Detection of Sentinel Nodes
研究概览
简要总结
45 patients undergoing a colon (large bowel/intestine)removal operation for the diagnosis of colon cancer will be included in this study. During colon operation the affected portion of the colon is removed. In addition, lymph nodes are included in the specimen and evaluated by a pathologist. Analysis of the lymph nodes in the specimen are important because this is an important aspect of determining the stage of the cancer.
Once the standard technique is used for the colon removal operation and the specimen is removed it will be injected with two drugs to help identify the lymph nodes. One is a blue dye and the other a radiotracer. The colon and ALL of the lymph nodes will then be sent for the standard pathologic evaluation. The patient themselves will never be injected with these drugs being used for research.
Following the standard lymph node evaluation, an additional pathologist at an outside research facility will further examine the lymph nodes in the specimen using more in depth techniques which are above and beyond the standard of care.
The results of all the pathologic tests will be conveyed to the surgeon of record to help in their decision making regarding further treatment.
The study hypothesis is that radiotracer will be at least as effective as blue dye in identifying the lymph nodes most likely to harbor cancer cells (sentinel nodes). Once identified, these sentinel nodes can then undergo a more in depth review leading to improved staging of colorectal cancer and more accurate treatment.
详细描述
This study is a single center, open-label, within patient's tissue ex vivo comparative study of Lymphoseek (Lymphoseek (Technetium Tc 99m Tilmanocept) is a radiotracer that accumulates in lymphatic tissue by binding to a mannose binding receptor that resides on the surface of dendritic cells and macrophages. Lymphoseek has a diameter of about 5 nm, which is substantially smaller than current radiolabeled agents used for targeting lymphoid tissue. Lymphoseek's small diameter permits enhanced diffusion into lymph nodes and blood capillaries, resulting in a rapid injection site clearance. Upon entry into the blood, the agent binds to receptors in the liver or is filtered by the kidney and accumulates in the bladder.)and vital blue dye (Patent Bleu V) in the detection of excised lymph nodes in patients with known cancer of the colon.
The colon segment with tumor and the anticipated involved nodal bed will be removed intact. After the surgical procedure is completed, the specimen is instantly taken to an extra table in the operating room. It is performed just after the specimen is taken out. The colonic specimen is incised longitudinally on the antimesenteric side.
Lymphatic mapping is employed on the specimen by using first injection Lymphoseek (50 µg/2 mCi) in 0.1-1.0 ml, followed in 15-30 min by 1 ml 1% blue dye, each injected subserosally and submucosally around the tumor (peritumoral sites employed) by using tuberculin syringe. After 5-7 minutes of massage with little circulatory movements on the lesion, the marking agents are moved into the lymphatic paths to the sentinel lymph nodes(SLN)in the mesentery.
By low level diathermy, sharp dissection of lymphatic path(s) to the SLN(s) may be existent.
Blue nodes shall be removed first by visual inspection. This inspection and dissection shall last not longer than 20 minutes. Each blue node will then be assessed for counts as well as color and the "hot" rule (3σ) applied as described below.
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
- All
- 接受健康志愿者
- 否
入选标准
- •The patient has provided written informed consent with Health Insurance Portability and Accountability Act (HIPAA) authorization.
- •The patient has a diagnosis of colon cancer and is a candidate for surgical intervention, with ex vivo lymph node mapping being a part of the surgical plan.
- •The patient is at least 18 years of age at the time of consent.
- •The patient has an Eastern Cooperative Oncology Group (ECOG) performance status of Grade 0 -
- •The patient has a clinical negative node status at the time of study entry (i.e., Tis-4, N0, M0).
排除标准
- •The patient has clinical or radiological evidence of metastatic cancer including palpably abnormal or enlarged lymph nodes.
- •The patient has undergone node basin surgery of any type or radiation to the nodal basin(s).
- •The patient has undergone radiation therapy or chemotherapy treatment within the previous 45 days.
研究组 & 干预措施
Lymphoseek and VBD SLN dissection
Ex-Vivo Lymphoseek and VBD SLN dissection
干预措施: Lymphoseek and VBD Sln dissection (Drug)
结局指标
主要结局
Efficacy of Lymphoseek for Detection of Sentinel Nodes
时间窗: 0-7 days
Number of Participants in Concordance of in vivo detection rates of Lymphoseek and VBD in excised lymph nodes as tissue phenotype is confirmed by histology.
次要结局
- Localization Rates(On the day of surgery i.e. day 0 of index operation)
研究者
Danny A Sherwinter
Attending, Surgery
Maimonides Medical Center