Role of Indocyanine Green (ICG) for Detection of Sentinel Nodes in Breast Cancer (FLUO-BREAST)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- The primary endpoint is the SN detection rate during surgery by fluorescence, by isotopes, by combining the two. The detection rate is defined by the number of patient
研究概览
简要总结
This is a single-center prospective study evaluating the diagnostic performance and safety of Infracyanine in women with early breast cancer whose the research of sentinel node(s) combines isotopes and Infracyanine.
详细描述
Visits:
Screening:
Complete physical and gynecological examination by surgical oncologist Informed and signed consent form. The intervention will be planned within one month.
Intervention:
In the beginning of the intervention, a periareolar injection of the Infracyanine will be carried out (Infracyanine®, 2ml to 2.5mg/ml whether 3.2nM).
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
- Female
- 接受健康志愿者
- 否
入选标准
- •Female age > 18 years
- •Invasive breast cancer ≤ 5 cm, unifocal bifocal or multifocal
- •Diagnosis confirmed by biopsy
- •Breast cancer extended in situ
- •First surgical treatment
排除标准
- •Neoadjuvant chemotherapy or hormone therapy.
- •Multicentric tumor
- •Pregnant patient
- •Ongoing participation in another clinical trial with an investigational drug
研究组 & 干预措施
Infracyanine
In the beginning of the intervention, a periareolar injection of the Infracyanine will be carried out (Infracyanine®, 2ml to 2.5mg/ml whether 3.2nM).
干预措施: Infracyanine (Drug)
结局指标
主要结局
The primary endpoint is the SN detection rate during surgery by fluorescence, by isotopes, by combining the two. The detection rate is defined by the number of patient
时间窗: During surgery
The detection rate is defined by the number of patient who at least one axillary sentinel node detected by fluorescence and / or isotope intraoperatively / number of female patients injected.
次要结局
- The sensitivity of indocyanine green compared to the technical reference ( percentage of nodes detected by the isotope and which are also detected by the indocyanine green )(During surgery)
- The wrong negative rate (number of female patients in whom at least one metastatic sentinel node has been detected by isotope and not by ICG)(During surgery)
- The time between the incision and removal of the first sentinel node identified(During surgery)
- Incidence rates of allergic reactions(From screening till 1 month after the surgery)
- Technical direct cost(during the study)
- Severity of allergic reactions (grade 1 to 5 according to Ring and al 38 )(From screening till 1 month after the surgery)