Role of Sentinel Lymph Node Identification in Patients With Breast Cancer Using SPECT/CT
试验速览
- 阶段
- 不适用
- 入组人数
- 4
- 主要终点
- Role of SPECT/CT in sentinel lymph node detection in breast cancer
研究概览
简要总结
Role of SPECT/CT in detection of sentinel lymph node in patients with breast cancer that is in early stage with small mass with no nodal or distant metastasis using radioactive material nannocolloid that can change surgical approach
详细描述
The status of axillary lymph node involvement is the best prognostic factor in patients with early stage breast cancer. In the past; removal of all of the axillary lymph nodes (axillary lymph node dissection, ALND) was often the preferred method of treatment.
ALND, however, has significant short- and long-term morbidity, the most significant being lymphoedema. With the trend towards earlier detection and presentation of breast cancer, most patients do not have lymphatic metastases at diagnosis.
In these patients, ALND is purely a diagnostic procedure, with no therapeutic benefit; besides the widespread use of breast conserving surgery, the staging procedure carries greater morbidity than the therapeutic procedure of the primary cancer.
Sentinel lymph nodes (SLNs) are defined as the first lymph nodes in a tumor bed that receive lymphatic drainage directly from the primary tumor; accordingly these nodes are most likely to harbor metastasizing cancer cells along the path of lymph drainage of tumor tissues, if lymphatic metastasis does occur.
SLN biopsy (SLNB) has been demonstrated to be an ideal option to accurately stage axillary nodal involvement in breast cancer; it is a minimally invasive technique for lymphatic staging. The accurate detection of the SLN is paramount for the success of the procedure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 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
- 是
入选标准
- •Patients 18≤ years' old, female gender.
- •Patients with histopathologically proven breast cancer.
- •Patients with early stage and invasive breast cancer stage T1 with mass no more than 2 cm in greatest dimension or stage T2 with mass more than 2 cm but no more than 5 cm in greatest dimension with no clinical evidence of axillary lymph node metastasis(N0) and no remote metastasis (M0).
排除标准
- •Patients with LABC, multifocal breast cancer or distant metastasis.
- •Clinical, histological or radiological evidence of regional nodal metastasis.
- •Prior major breast or axillary operations that could interfere with lymphatic drainage.
- •Pregnancy.
- •Inability to sign informed consent.
结局指标
主要结局
Role of SPECT/CT in sentinel lymph node detection in breast cancer
时间窗: 3 years
Early detection of sentinel lymph node in patients with breast cancer using SPECT/CT by radioactive material nanocolloid to change surgical approach
次要结局
未报告次要终点
研究者
Raghda Hassan Mohamed Farweiz
Assiut Medical School Ethical Review Board
Assiut University
