A Prospective Single-center Cohort Study "Preoperative Identification of Sentinel Lymph Nodes Using Contrast-enhanced CT Lymphography in Breast Cancer Patients"
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 31
- 试验地点
- 2
- 主要终点
- Sensitivity and specificity of contrast-enhanced CT lymphography
研究概览
简要总结
The main hypothesis of this study is that contrast-enhanced CT lymphography can be used for preoperative visualization of sentinel lymph nodes in breast cancer patients. We assume that CT lymphography is a high-sensitivity and high-specificity method for sentinel lymph nodes' mapping in breast cancer patients. We also assume that positive predictive value and negative predictive value for identification of presence or absence of metastases in sentinel lymph nodes (SLN) will be high enough for preoperative diagnosis of SLN metastases in breast cancer patients. This study will use CT lymphography with periareolar injection of iopamidol and standard protocols of sentinel lymph nodes biopsy using intraoperative indocyanine green (ICG) fluorescence.
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 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age > 18 years;
- •Signed informed consent;
- •Histologically confirmed breast cancer
排除标准
- •Iodine allergy;
- •Presence of distant metastases of breast cancer;
- •Body mass index more than 40;
- •Chronic cardiovascular and cerebrovascular diseases in the stage of decompensation or recent acute conditions (myocardial infarction, brain stroke, etc.)
- •Suspected pregnancy;
- •Severe hypothyroidism;
- •Bronchial asthma in the stage of decompensation;
- •Decompensated diabetes;
- •Kidney or hepatic failure.
结局指标
主要结局
Sensitivity and specificity of contrast-enhanced CT lymphography
时间窗: 8 months
First primary endpoint is to determine the sensitivity and specificity of contrast-enhanced CT lymphography for the preoperative detection of sentinel lymph nodes in breast cancer in comparison with the intraoperative fluorescence method.
Preoperative detection of sentinel lymph nodes metastases
时间窗: 8 months
Second primary endpoint is to assess the capabilities of contrast-enhanced CT lymphography for detecting metastases in sentinel lymph nodes in breast cancer patients
次要结局
- Objective criteria for metastatic lesions of sentinel lymph nodes(8 months)
研究者
Ruslan Ahmedov
MD
Saint Petersburg State University, Russia