Evaluation of Near- InfraRed Imaging of ICG in Comparison With the Lymphoscintigraphic Technique Using Intramammary and Peritumoral Injection of 99mTc-HSA-Nanocolloids for the SLN Detection in BC Patients.
试验速览
- 阶段
- 2 期
- 入组人数
- 214
- 试验地点
- 1
- 主要终点
- false negative rate for each technique (fluorescence and radiocolloids)
研究概览
简要总结
The revision of our data shows that since its introduction in our institution (Jules Bordet Institute) in 1998 (until 2010, the year of the last review of cases), 53 patients underwent neoadjuvant therapy before selective sentinel lymph node dissection followed by conventional axillary dissection.
The analysis of these cases shows that:
- The lack of demonstration of sentinel lymph nodes observed in 8 cases (6 cN0) is associated in 75% of them with a pN+ status
- If scintigraphic imaging is "positive" (demonstration of the sentinel lymph nodes: 35 cN0 and 10 cN+), our results appear favorable with a single false negative SLN result (False Negative Rate = 1/20 or 5%).
Therefore we propose additional technique for LN detection by indocyanine green, we hypothesize that the combination of two different injections improves the technique of sentinel lymph node biopsy.
详细描述
The principal objective of this study is to evaluate the detection rate, the false negative rate and the overall accuracy of the lymphofluoroscopic research of the sentinel lymph nodes after periareolar injections of Indocyanine Green (ICG) in combination and in comparison with our classical intramammary and peritumoral injections of 99mTc-HSA-Nanocolloids in patients with breast cancer. These patients are currently out of the inclusion criteria and still undergo systematically complete axillary node dissection.
In this study (which would include at least 200 patients over a period of 2 years, with at least 100 patients after neoadjuvant chemotherapy) the involved surgeons would continue to perform complete axillary node dissections.
The radioactive SLN would be retrieved ex vivo in the axillary piece (with the gamma probe, after intramammary and peritumoral injections of radiocolloids the day before the surgery, or at least 3 hours before, with scintigraphic preoperative images as already performed routinely for patients described in the introduction 1 of this letter). These radioactive lymph nodes would thereafter been controlled for their possible fluorescence (with our fluorescence camera and after periareolar injection of ICG in the operating room just before the surgery). Finally, in the service of Pathology, all the lymph nodes found by the pathologist in the axillary piece will be controlled for their possible fluorescence.
With this approach, the surgeon will not have to search for SLN and the operative duration will not be extended.
Secondary objectives:
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 patients submitted to mastectomy or tumorectomy with Complete Axillary Node Dissection (but to whose SLN procedure might be proposed in the future).
- •General operability.
- •Informed consent form signed
排除标准
- •Age less than18 years old.
- •Former operation in the axilla and/or breast.
- •Any previous radiotherapy at the concerned breast and/or axilla and/or chest wall.
- •History of allergy or hypersensitivity against the investigational product (its active substance or ingredients), to iodine or to shellfish.
- •Apparent hyperthyroidism, autonomous thyroid adenoma, unifocal, multifocal or disseminated autonomies of the thyroid gland.
- •Documented coronary disease.
研究组 & 干预措施
Indocyanine Green
superficial injections of Indocyanine Green in the breast
干预措施: Indocyanine Green (Drug)
结局指标
主要结局
false negative rate for each technique (fluorescence and radiocolloids)
时间窗: 1 week
次要结局
未报告次要终点