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临床试验/NCT00952679
NCT00952679Unknown3 期

Computed Tomography (CT) Based Lymphatic Mapping and Localization of Sentinel Lymph Node in Breast Cancer Patients

Fudan University1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2009年1月最近更新:
适应症

试验速览

阶段
3 期
入组人数
50
试验地点
1
主要终点
all cause mortality

研究概览

简要总结

Breast cancer patients who diagnosed by core needle biopsy or excisional biopsy underwent CT scan to locate the sentinel lymph node (SLN) before SLN biopsy (SLNB) at the same day of surgery. When CT examination performed, those patients were in supine position, with the arms stretched upward but bent at the elbow with the hands at the side of the cranium which similar to the surgical position. After local anesthesia, 2mL of iopamidol was injected subcutaneously to the peritumoral and peri-areolar areas followed by gentle massage for about 1 minute. Contiguous 2-mm-thick CT images that included the breast and axilla were obtained prior to administration of the contrast agent. After 3D CT reconstruction, the SLN was identified as the most inferiorly visible nodule in the axilla connected to the lymphatic vessel on the CT imaging monitor. A professional intervention doctor punctured the defined lymph node guided by the CT monitor using the Breast Lesion Localization Needles (interv). The needle would stay in the patient's axilla until the surgery. All the lymph nodes including the CT defined one and which marked by methylene blue dye or 99mTc-sulfur colloid tracers were removed, which then would be tested by touch imprint cytology for the intraoperative diagnosis. Patients who had positive SLN would receive axillary dissection. The investigators evaluated the new method by comparing lymph nodes defined by CT and traditional ways.

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 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Breast cancer patients(T1-T2N0)
  • Age 18-70
  • Accept of SLNB
  • Accept our protocol in the informed consent

排除标准

  • LABC patients
  • Age < 18
  • History of epilepsy
  • History of thyrotoxicosis
  • Pregnant women

结局指标

主要结局

all cause mortality

时间窗: five years

次要结局

未报告次要终点

研究者

申办方类型
Other

研究点 (1)

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