Evaluation of the Technique of Axillary Sentinel Lymph Node (SLN) Detection in Breast Cancers > 2 cm
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 249
- 试验地点
- 44
- 主要终点
- Quality criteria of the SLN detection technique
研究概览
简要总结
The purpose of this study is to evaluate the quality criteria of the SLN detection technique in breast cancer patients with a tumor size (clinical measurement) greater than 2 centimeters (rate of false negatives, rate of detection).
Eligible patients will only be registered (no randomization). The estimated inclusion period is approximately 24 months. The duration of the research is 25 months (24 months for patient inclusion + 1 month for reception of results). The maximum participation duration of each patient is 1 month.
The number of patients required in this multicentric and prospective study is 240 (16 participating centers).
详细描述
Axillary node extension is one of the major prognostic factors in breast cancer. Axillary dissection of Berg level I and II nodes is the validated method to obtain information on lymph node invasion, but it is associated with important morbidity.
Sentinel lymph node assessment (SLN) was developed to select patients likely not to have axillary node extension using a technique less invasive than conventional dissection. Axillary dissection is restricted to patients with undetected or metastatic SLN.
SLN detection involves subareolar or peri-tumoral injection of lymphotropic contrast agents which map the regional lymphatic drainage pattern of the tumor.
This technique allows an optimization of histopathological analysis: the pathologist must analyze only two nodes on average (instead of 10-15), allowing the examination of numerous tissue sections and the development of specific techniques such as immunohistochemistry.
The principal indicators of success for the technique are the detection rate, the false negative rate and the number of SLN sampled.
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, age ≥ 18 years
- •Patient with invasive unifocal breast cancer with tumor size > 2 cm at initial examination (clinical examination and/or imaging)
- •Preoperative histological diagnosis of infiltrating mammary carcinoma
- •No lymph node at clinical examination
- •No treatment for this cancer before surgery
- •Mandatory affiliation with a social security system
- •Written, signed informed consent
排除标准
- •No invasive breast cancer
- •Breast tumor =< 2 cm
- •Preoperative histological diagnosis other than infiltrating mammary carcinoma
- •Multifocal breast cancer
- •Inflammatory breast cancer
- •Metastatic cancer
- •History of homolateral breast surgery
- •History of allergic disorders
- •History of homolateral breast cancer
- •Difficult follow-up
- •Pregnant or lactating woman
- •Previous inclusion in the trial
研究组 & 干预措施
No label
Injection of Nanocis® or Nanocoll® (Tc-colloid) on the day before surgery followed by lymphoscintigraphy (long protocol, method n°1) or injection of Nanocis® or Nanocoll® on the morning of the surgery followed by lymphoscintigraphy at least 2h30 later (short protocol, method n° 2)
干预措施: No name (Other)
结局指标
主要结局
Quality criteria of the SLN detection technique
时间窗: 1 month
次要结局
- Total number of sampled SLN per patient(1 month)
- Histopathological results (SLN)(1 month)
- Histopathological results (dissection)(1 month)
- Detection of SLN by means of extra-axillary markings (lymphoscintigraphy)(1 month)