Magnetic Particle-ICG Lymph Node Mapping in Colorectal Cancer
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 主要终点
- To assess the feasibility how the Sentinel Lymph Node (SLN) mapping by using novel magnetic tracers (FerroTrace) and using the indocyanine green (ICG) for colorectal cancer.
研究概览
简要总结
Study to determine the feasibility of Sentinel Lymph Node (SLN) mapping using novel magnetic tracers (FerroTrace) and indocyanine green (ICG) for colorectal cancer; and to evaluate safety by assessing short term toxicity associated with colonoscopic peritumoral injection of novel magnetic nanoparticles (FerroTrace) and ICG for colorectal cancer.
详细描述
PRIMARY:
- To determine the feasibility of Sentinel Lymph Node (SLN) mapping using novel magnetic tracers (FerroTrace) and indocyanine green (ICG) for colorectal cancer.
- To evaluate safety by assessing short term toxicity associated with colonoscopic peritumoral injection of novel magnetic nanoparticles (FerroTrace) and ICG for colorectal cancer.
SECONDARY:
- To determine the additional positive diagnostic value of adding sentinel lymph node mapping to lymphadenectomy by assessing the SLNs with detailed immunochemistry versus the normal H&E staining pathology tests.
PRIMARY END POINTS:
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
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
FerroTraceTM (magnetic tracer)
a special type of fluorescent dye called indocyanine green (ICG) during surgery can help surgeons find the lymph nodes that the cancer is most likely to have spread to in colorectal cancer patients.
干预措施: FerroTraceTM (Device)
FerroTraceTM (magnetic tracer)
a special type of fluorescent dye called indocyanine green (ICG) during surgery can help surgeons find the lymph nodes that the cancer is most likely to have spread to in colorectal cancer patients.
干预措施: indocyanine green (ICG) (Drug)
结局指标
主要结局
To assess the feasibility how the Sentinel Lymph Node (SLN) mapping by using novel magnetic tracers (FerroTrace) and using the indocyanine green (ICG) for colorectal cancer.
时间窗: through study completion, an average of 1 year
次要结局
未报告次要终点