INFLUENCE II - a Pilot Study for Implementation Identification of Sentinel Lymph Nodes in Breast Cancer Patients Through Non-invasively FLUorEsceNt Imaging Using indoCyaninE Green: a Pilot Study for Implementation
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Identification rate of SLNs achieved by 99mTc-nanocolloid or the fluorescent signal of ICG
研究概览
简要总结
This single-institution pilot study uses a pre- and post-implementation design to evaluate the implementation of ICG fluorescent imaging for sentinel lymph node biopsy (SLNB) in an Italian hospital.
详细描述
Pre-implementation: standard sentinel node procedure using 99mTc-nanocolloid, which implies 99mTc injection the day or the morning before surgery. Transition period: participating surgeons will receive on-site training, proctoring, and ongoing guidance from experienced surgeons and early adopters of the ICG method from St. Antonius Hospital, Utrecht, The Netherlands until they achieve confidence and proficiency in using ICG for SLNB. Post-implementation: 5 mg (2 ml) ICG will be injected periareolar after administration of general anesthesia and before incision. The SLN will be visualized by fluorescent imaging using a fluorescence camera.
Main study endpoints: Primary endpoint is the identification rate of SLNs achieved by 99mTc-nanocolloid or the fluorescent signal of ICG. Secondary endpoints are total number of LNs removed, detection time, total operative time, complications and (serious) adverse events, loco regional recurrence after 1 year follow-up, pre-implementation expectations regarding ICG, post-implementation experiences regarding ICG including barriers and success factors.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 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
- •Clinically node-negative, DCIS or invasive stage T1-T3 breast cancer confirmed by biopsy
- •Preoperative axillary ultrasound to confirm clinical node-negative status
- •Indication for breast cancer surgery with SLNB via axillar incision
- •Written informed consent according to national regulations
排除标准
- •Patients < 18 years old.
- •Indication for breast cancer surgery with SLNB via mastectomy incision
- •Known allergy for ICG, intravenous contrast or iodine
- •History of axillary lymph node dissection
- •Pregnancy or breast-feeding
- •Psychological, familial, sociological or geographical factors that could potentially hamper compliance with the study protocol
研究组 & 干预措施
99mTc
radioisotope technetium technique will be used for sentinel lymph node localization(99mTc)
干预措施: technetium 99 used as a tracer for sentinel lymph node (Procedure)
ICG
indocyanine green fluorescent imaging technique will be used for sentinel lymph node localization (ICG)
干预措施: ICG used as a tracer for sentinel lymph node (Procedure)
结局指标
主要结局
Identification rate of SLNs achieved by 99mTc-nanocolloid or the fluorescent signal of ICG
时间窗: through study completion, an average of 1 year
measure the percentage of sentinel lymph nodes identified by the 99mTc nanocolloid or the ICG fluorescent signal (%)
次要结局
- Percentage of SLNs that has 99mTc uptake/ is fluorescent(through study completion, an average of 1 year)
- Detection time(through study completion, an average of 1 year)
- Total operative time(through study completion, an average of 1 year)
- Number of complications and (serious) adverse events(through study completion, an average of 1 year)
- loco regional recurrence after 1 year follow-up(through study completion, an average of 1 year)
- The pathology of SLNs identified(through study completion, an average of 1 year)