Infrared Fluorescence Guided Surgery for Sentinel Node Identification in Cutaneous Melanoma
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 318
- 试验地点
- 1
- 主要终点
- Sensibility of the sentinel node biopsy
研究概览
简要总结
Sentinel node biopsy is a surgical procedure used to find melanoma lymph node metastasis (i.e. groin/axilla) in very early stages. This study aims to add a new technology over the standard procedure - a fluorescent contrast (indocyanine green) using special light (near infra-red) - looking for more precise diagnosis of the presence of the lymph node metastasis.
详细描述
The main objectives of this study is perform a new technique added to the usual procedure for sentinel lymph node biopsy for cutaneous melanoma. The fluorescence surgery consists in a injection of indocyanine green around the primary tumor, or, when already excised (excisional biopsy), the biopsy site at the beginning of the surgery. Patient performs, in a standard fashion, the lymph scintigraphy prior the surgery and is injected at the same time a blue die similarly the indocyanine green. Immediately after the indocyanine infusion, the injection site is massaged and a near infra red light (NIR) is focused over it. An appropriated infra red camera is positioned over the lymphatic pathway, searching for the fluorescence and localizing the sentinel node at the basin. The skin is opened and the sentinel node is resected. The success or not in localizing the sentinel node is pointed and the standard techniques are applied - gamma probe and surgical location of a blue lymph node. All sentinel node characteristics are noted as number, which technic identified it, time, location. Later information will be gathered as histological status, surgical complications, recurrence and survival.
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
- •Patients eligible for sentinel node biopsy in standard care
排除标准
- •Previous neoplasia
- •Previous surgery or scar in the lymph node basin or primary tumor, except primary tumor biopsy
- •Local recurrence
- •Hypersensibility or allergy history to indocyanine or Iodine-based contrast media
研究组 & 干预措施
Near infra red sentinel node biopsy
Sentinel node biopsy adding indocyanine green injection at the tumor/biopsy site during the surgical procedure to the standard technique (blue die and lymph scintigraphy) and near infra red light for fluorescence. The indocyanine green saline solution - 5mg diluted in 10ml. will be injected in 4 points around the biopsy site - 4ml each - total 0.8mg - single procedure.Near infra red lens and camera will be used to detect the fluorescence and localize the sentinel node for biopsy.
干预措施: Near infra red sentinel node biopsy (Procedure)
Near infra red sentinel node biopsy
Sentinel node biopsy adding indocyanine green injection at the tumor/biopsy site during the surgical procedure to the standard technique (blue die and lymph scintigraphy) and near infra red light for fluorescence. The indocyanine green saline solution - 5mg diluted in 10ml. will be injected in 4 points around the biopsy site - 4ml each - total 0.8mg - single procedure.Near infra red lens and camera will be used to detect the fluorescence and localize the sentinel node for biopsy.
干预措施: Indocyanine green (Drug)
Near infra red sentinel node biopsy
Sentinel node biopsy adding indocyanine green injection at the tumor/biopsy site during the surgical procedure to the standard technique (blue die and lymph scintigraphy) and near infra red light for fluorescence. The indocyanine green saline solution - 5mg diluted in 10ml. will be injected in 4 points around the biopsy site - 4ml each - total 0.8mg - single procedure.Near infra red lens and camera will be used to detect the fluorescence and localize the sentinel node for biopsy.
干预措施: Intraoperative Near-Infrared Imaging System (Device)
结局指标
主要结局
Sensibility of the sentinel node biopsy
时间窗: Time of surgery
The successful rate of the sentinel node localization and biopsy. The standard technique and the experimental one will be assessed
次要结局
- Specificity of the sentinel node biopsy(60 months)