跳至主要内容
临床试验/NCT03468374
NCT03468374Unknown不适用

Role of Sentinel Lymph Node Identification in Patients With Breast Cancer Using SPECT/CT

Assiut University0 个研究点目标入组 4 人开始时间: 2018年7月最近更新:
适应症

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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Raghda Hassan Mohamed Farweiz

Assiut Medical School Ethical Review Board

Assiut University

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