Diagnostic Accuracy of Indo Cyanine Green guided Sentinel lymph node biopsy after Neoadjuvant treatment in Breast Cancer
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- JIPMER
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- To assess the Sensitivity and specificity of Indo Cyanine
研究概览
简要总结
Background: In breast cancer Axillary lymph node status is one of the most
important prognostic factors in patients with
breast cancer. Axillary lymph node dissection is
an integral part of surgical management.
However, it may lead to increased morbidity
such as impaired sensation (56%), Chronic pain (37%) and also debilitating lymphedema
(21.4%) in some patients which is irreversible
leading to poor functional outcome
Rationale : ICG is a tricarbocyanine dye which fluoresces,
i.e. emits light, after excitation under near-
infrared light at 806)nm light. ICG is highly
soluble in water and binds to β-lipoproteins,
particularly to albumin. Because of the high
protein content of lymph, ICG accumulates in
the lymphatic pathways and lymph nodes. ICG-
dyed lymph nodes become visible 5 minutes
after light excitation and remain visible for
around 60 minutes
Optical imaging using the near-infrared (NIR)
üuorescence lymphatic tracer using indocyanine
green (ICG) has shown promising results as an
alternative for, or an addition to, conventional
SLN mapping.
The role of ICG fluorescence alone in detecting
SLNin the post neoadjuvant treatment setting
has been reported in a few studies.
Expected outcome:The expected outcome of the study is to know
the accuracy of ICG in the identification of
sentinel lymph nodes after neoadjuvant
treatment in carcinoma breast patients
undergoing surgery. If found to be accurate, this
study could contribute to de-escalating the
axillary management among breast cancer patients in the post neoadjuvant treatment
setting.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients with age 18 years or older
- •ECOG Performance Status of 0 to 2
- •Breast cancer with clinically node negative after neoadjuvant treatment.
排除标准
- •Previous Surgery/Radiotherapy to breast or axilla.
- •Pregnant or nursing mothers.
- •Patients with ICG allergy
- •Patients with Extra axillary lymph nodes 6.Patients with distant metastasis
- •Patients not giving consent for SLNB
- •Progressive disease after Neoadjuvant treatment.
结局指标
主要结局
To assess the Sensitivity and specificity of Indo Cyanine
时间窗: At baseline and at 4 weeks
Green (ICG) for detecting sentinel lymph nodes after
时间窗: At baseline and at 4 weeks
neoadjuvant treatment among breast cancer patients
时间窗: At baseline and at 4 weeks
undergoing surgery.
时间窗: At baseline and at 4 weeks
次要结局
- Sentinel node Identification rate, False negativity rate(at 4 weeks)
研究者
Dr.Sharmila beevi.J
JIPMER