Preoperative Identification of the Sentinel Lymph Node in Breast Cancer, Using Ultrasound and Radio-isotope/Percutaneous Gamma Probe
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- NHS Tayside
- 入组人数
- 59
- 试验地点
- 2
- 主要终点
- Is the sentinel lymph node marked preoperatively confirmed as the SLN at surgery?
研究概览
简要总结
When a person has breast cancer it is necessary to find out whether the cancer has spread to the lymph nodes in the armpit because if it has, further treatment is likely to be needed. There are many of these nodes but when the breast cancer spreads, it does so in a step-by-step fashion, starting with the so-called Sentinel Lymph Node (SLN). At present, the only way to be sure whether there is cancer in the lymph nodes or not is to perform an operation to remove at least the SLN. If the pathologist finds cancer in the SLN, a second operation is usually required to remove further nodes in case they contain cancer too. Surgical removal of the lymph nodes in the armpit can cause difficulties for the patient afterwards, such as pain and swelling in the arm. If there is no cancer in the SLN, no further operations on the armpit are needed. The investigators wish to find out whether in some patients, operations on the armpit can be avoided completely. The first step in doing this is to test whether the investigators can find out which is the SLN before the operation, using a combination of an injection and ultrasound scanning. The injection - into the skin of the breast - would be a radioactive substance, which is the usual way the surgeon finds the SLN. The radioactive substance collects in the SLN and the investigators would use a "gamma probe" over the surface of the armpit to detect the radiation. In this initial study, the investigators would aim to find the SLN before the operation and place a marker wire in it so that the surgeon could check whether the investigators had found the correct node.
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
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with invasive breast cancer suitable for primary surgical treatment
- •Booked for surgical Sentinel Lymph Node Biopsy
排除标准
- •Unable to give informed consent
- •Known bleeding disorder
- •Previous axillary surgery
- •Previously treated for the current tumour with chemotherapy or hormone therapy
研究组 & 干预措施
Single arm study - Sentinel Node Localisation
干预措施: Preoperative sentinel lymph node identification and marking (Procedure)
结局指标
主要结局
Is the sentinel lymph node marked preoperatively confirmed as the SLN at surgery?
时间窗: 8 Months from start of trial.
次要结局
未报告次要终点
研究者
Andy Evans
Professor of Breast Imaging
NHS Tayside
