Indocyanine Green Guided Identification of Sentinel Lymph Nodes Via Mastectomy Incision in Breast Cancer Patients (INIGMA Study)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- Identification rate of sentinel lymph nodes using indocyanine green fluorescence
研究概览
简要总结
This pilot study evaluates the diagnostic value of indocyanine green (ICG) fluorescence for sentinel lymph node biopsy (SLNB) performed through the mastectomy incision in breast cancer patients.
Women with clinically node-negative, invasive T1-T3 breast cancer undergoing mastectomy with SLNB at St. Antonius or Isala Hospital will be included. All patients receive standard 99mTc injection preoperatively, followed by 5 mg (2mL) ICG injection after anesthesia. The axilla will be explored for fluorescent lymph nodes via the mastectomy incision, avoiding a separate axillary incision.
Primary outcome: ICG detection rate for SLN identification via the mastectomy incision.
Secondary outcomes: Comparison with 99mTc detection, number of nodes identified, concordance between methods, pathology differences, detection time, and complications.
ICG is safe, non-ionizing, and causes no extra discomfort or visits. Risks and burden are minimal.
详细描述
Background:
Identifying lymphatic metastases is an important prognostic factor in the survival rate of breast cancer and the presence of lymphatic metastases carries consequences for further treatment. Results the non-inferiority INFLUENCE study and previous literature, led to the implementation of ICG-guided SLNBs via axillary incision as standard of care at the St. Antonius Hospital. The diagnostic performance of ICG-fluorescence for SNLBs using the mastectomy incision has not been described yet. Surgeons may perform SLNBs using the same incision as the mastectomy, rather than using an additional axillary incision. In such setting, extended operating distance and visualization with an improper angle might introduce challenges to identify the SLN by tracking lymphatic vessels into the axilla.
Objective:
This pilot study aims to identify the diagnostic value of indocyanine green (ICG) fluorescence imaging for SLNBs via the mastectomy incision.
Study design:
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
- •Clinically node-negative, DCIS, invasive T1- T3 breast cancer confirmed by biopsy.
- •Preoperative axillary ultrasound to confirm clinical node-negative status.
- •Indication (or preference) for mastectomy and simultaneous SLN procedure.
- •Written informed consent according to ICH/GCP and national regulations.
排除标准
- •Patients < 18 years old
- •Breast conserving surgery
- •Direct reconstruction (with autologous tissue or implant)
- •Known allergy for indocyanine green (ICG) or radioisotope technetium (99mTc), intravenous contrast or iodine
- •Other concurrent solid tumour
- •Hyperthyroidism or thyroid cancer
- •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
ICG-fluorescence imaging with 99mTc control for SLNB
This experimental arm involves participants receiving indocyanine green (ICG) fluorescence imaging as the primary method for sentinel lymph node biopsy (SLNB), with 99mTc-nanocolloid serving as the within-patient control. Both methods are applied during the same surgical procedure. This design allows each participant to serve as their own control for comparing the diagnostic perfomance of both techniques directly in indentifying sentinel lymph nodes via mastectomy incision.
干预措施: Indocyanine green (ICG)-fluorescence guided sentinel lymph node biopsy (Other)
结局指标
主要结局
Identification rate of sentinel lymph nodes using indocyanine green fluorescence
时间窗: During the surgical procedure (from skin incision to completion of sentinel lymph node resection)
The identification rate is defined as the proportion of participants in whom at least one sentinel lymph node (SLN) is successfully identified using indocyanine green (ICG) fluorescence imaging via the mastectomy incision during surgery.
次要结局
- Identification rate of sentinel lymph nodes using 99mTc(During the surgical procedure (from skin incision to completion of sentinel lymph node resection))
- Difference in sentinel lymph node detection rate between ICG and 99mTc(During the surgical procedure (from skin incision to completion of sentinel lymph node resection))
- Number of sentinel lymph nodes identified per participant by ICG and 99mTc(During the surgical procedure (from skin incision to completion of sentinel lymph node resection))
- Proportion of participants with fluorescent sentinel lymph nodes among those identified by 99mTc(During the surgical procedure (from skin incision to completion of sentinel lymph node resection))
- Fluorescent sentinel lymph nodes not positive for 99mTc(During the surgical procedure (from skin incision to completion of sentinel lymph node resection))
- Sentinel lymph nodes positive for 99mTc but not fluorescent(During the surgical procedure (from skin incision to completion of sentinel lymph node resection))
- Pathological status of sentinel lymph nodes identified by ICG and 99mTc(From surgical resection of sentinel lymph nodes until completion of histopathological assessment, assessed within approximately 3 weeks after surgery)
- Detection time for sentinel lymph node identification using ICG(During the surgical procedure (from skin incision to sentinel lymph node resection))
- Procedure-related complications associated with ICG and 99mTc(From surgery up to 2 months postoperatively)
- Serious adverse events related to ICG and 99mTc(From surgery up to 2 months postoperatively)
研究者
Isabelle Henskens
Coordinating investigator
St. Antonius Hospital