Reliability of Indocyanine Green Use in Sentinel Lymph Node Identification in Cancer Surgery
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 744
- 试验地点
- 2
- 主要终点
- Non-inferiority of indocyanine green guided sentinel lymph node biopsy
研究概览
简要总结
This is a single-center prospective clinical trial to evaluate non-inferiority of indocyanine green guided sentinel lymph node biopsy compared with the gold standard Technecium99 guided sentinel lymph node biopsy in patients with cancers and subjected to surgery.
The diagnostic performance and the tolerance of indocyanine green (ICG) to the radio-isotope (Techniciun99) in the detection of sentinel lymph nodes will be assess using an "Optonuclear" probe (EURORAD S.A.) and QUEST camera
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
- •age >18 years
- •cancer histologically proved
- •patient eligible for sentinel node detection
- •contraceptive methods for men and women of childbearing age
- •signed informed consent form
- •patient affiliated to the social security system
排除标准
- •neoadjuvant chemotherapy or hormone therapy
- •adenopathy (s) clinically suspicious or positively cytopenic
- •women who are pregnant or breast-feeding
- •associated pathology that may prevent patient of receive indocyanine green
- •ongoing participation in another clinical trial with an investigational drug
- •patients deprived of liberty or under supervision
- •impossibility to undergo medical follow-up of the trial for geographical, social or psychological reasons
研究组 & 干预措施
sentinel lymph node detection
Each patient receive both injections of Technetium99 (standard care) and indocyanine green.
The detection of sentinel lymph node will be conducted by an optonuclear probe able to detect the radioactive and the fluorescence signal during surgery.
干预措施: Indocyanine green (Drug)
sentinel lymph node detection
Each patient receive both injections of Technetium99 (standard care) and indocyanine green.
The detection of sentinel lymph node will be conducted by an optonuclear probe able to detect the radioactive and the fluorescence signal during surgery.
干预措施: Optonuclear probe (Device)
sentinel lymph node detection
Each patient receive both injections of Technetium99 (standard care) and indocyanine green.
The detection of sentinel lymph node will be conducted by an optonuclear probe able to detect the radioactive and the fluorescence signal during surgery.
干预措施: Technetium99 (Drug)
sentinel lymph node detection
Each patient receive both injections of Technetium99 (standard care) and indocyanine green.
The detection of sentinel lymph node will be conducted by an optonuclear probe able to detect the radioactive and the fluorescence signal during surgery.
干预措施: Quest Camera (Device)
结局指标
主要结局
Non-inferiority of indocyanine green guided sentinel lymph node biopsy
时间窗: 1 day
The detection rate is defined by the number of patient who at least one sentinel node detected by fluorescence or isotope intra operatively. Per-operative detection is defined by the identification of at least one sentinel lymph node in the lymphatic drainage area.
次要结局
- Total number of sentinel lymph node detected(1 day)
- Number of false negative result(1 day)
- Allergic reactions(8 days)
- Evaluation of pain(1 day)
- fluorescence imaging(1 day)