Sentinel lympH Node Biopsy With Indocyanine Green in Breast Cancer After NEoadjuvant Chemotherapy (SHINE): A Prospective Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Non-inferiority of ICG SLNB compared to dual-tracer SLNB in post-neoadjuvant chemotherapy treated breast cancer patients.
研究概览
简要总结
This is a prospective, open-label, within-patient clinical trial to determine the accuracy of Indocyanine green (ICG) guided sentinel lymph node biopsy (SLNB) compared to the standard dual-tracer SLNB in breast cancer patients who have had chemotherapy as a first treatment using a non-inferiority design.
Patients with operable breast cancer treated with chemotherapy and eligible for SLNB will be included in the study. During surgery, ICG will be injected and used to identify fluorescent sentinel nodes using a hand-held imaging camera; radiotracer and blue dye will also be used as per standard protocols. Intraoperative and clinicopathologic outcomes such as complications, characteristics of nodes, false negative rates and feasibility will be assessed. Patients will be asked to complete standardized patient reported outcome questionnaires (Breast-Q, FACT-B+4, VAS) to define the patient experience with this novel technique.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults ≥ 18 and ≤ 80
- •Stage I-III core biopsy confirmed invasive breast cancer, who have undergone neoadjuvant chemotherapy and are planned to undergo SLNB with dual tracer (blue dye+Tc-99m)
- •Eastern Cooperative Oncology Group (ECOG) < 2
- •No ICG/iodine allergy
- •Capable of providing informed consent
- •English literacy
排除标准
- •Significant medical comorbidities (ASA 4)
- •Breast cancer stage T4/inflammatory or N2 disease at presentation (SLNB is contra-indicated in this setting)
- •Clinical node positive after neoadjuvant therapy (SLNB is contra-indicated in this setting)
- •Previous axillary surgery or breast/axillary radiotherapy to ipsilateral breast
- •Active pregnancy or breastfeeding
结局指标
主要结局
Non-inferiority of ICG SLNB compared to dual-tracer SLNB in post-neoadjuvant chemotherapy treated breast cancer patients.
时间窗: From Technetium-99 (Tc-99m) injection to the completion of surgery
Proportion of lymph nodes identified with ICG compared to the proportion of lymph nodes identified with dual tracer (blue dye/Tc-99m gamma probe)
次要结局
- Patient reported outcome measures - Visual Analog Scale(From baseline/enrolment to 12 months from surgery)
- Patient reported outcome measures - Breast-Q(From baseline/enrolment to 12 months from surgery)
- Complications/safety(From time of Technetium-99 (Tc-99m) injection to 30 days after surgery)
- Patient reported outcome measures - FACT-B+4(From baseline/enrolment to 12 months from surgery)