Injection of 99mTc-nanocolloid and ICG to Identify, Retrieve and Qualify Tumor Draining Lymph Nodes in Early-stage Lung Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- Feasibility of SLN procedure
研究概览
简要总结
The patient wil receive intra- or peritumoral injections of 99mTc-nanocolloid if malignancy is found during a navigation bronchoscopy. A SPECT/CT-scan will be made to image injections sites and sentinel lymph nodes (SLN). If surgery takes place to treat the lung cancer, ICG will be injected and fluorescent lymph nodes will be extensively assessed by a pathologist.
详细描述
When malignancy is found during navigation bronchoscopy, study participants will receive intra- or peritumoral injections of 99mTc-nanocolloid. Following, up to 2 SPECT/CT-scans will be made to assess drainage of the injected tracer to the lymph nodes.
If patients undergo resection of the lung lesion, ICG will be injected. The involved lung tissue will be removed, followed by routine complete lymph node dissection. The fluorescent lymph nodes will be more extensively evaluated by the pathologist.
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
- •ASA physical status 1-3;
- •Lung lesion between 1 and 5 cm;
- •Imaging-based disease free lymph nodes (N0);
- •Patient is deemed a candidate for definitive lung tissue resection by a thoracic surgeon.
排除标准
- •Pregnancy;
- •Inability to consent;
- •Known or suspected allergy to 99mTc-nanocolloid or ICG.
研究组 & 干预措施
Intervention
One interventional arm that will undergo all interventional procedures (when applicable).
干预措施: 99mTc-nanocolloid (Radiation)
Intervention
One interventional arm that will undergo all interventional procedures (when applicable).
干预措施: ICG (Drug)
结局指标
主要结局
Feasibility of SLN procedure
时间窗: During the study intervention
This is a qualitative outcome measurement that will be assessed by the involved physicians based on the ability to inject 99mTc-nanocolloid and ICG, and the ability to detect the tumor draining lymph nodes based on their drainage patterns.
次要结局
- Number of SLN found by SPECT/CT-imaging(On the day of the first intervention)
- Successfulness of injection method (intra- or peritumoral)(During the first intervention)
- Number of SLN found by ICG(On the day of the second intervention)
- Number of metastasis found by additional pathology(Up to two weeks after the second intervention)