跳至主要内容
临床试验/NCT00357487
NCT00357487已完成不适用

Sentinel Lymph Node Identification in Case of Breast Cancer. Clinical Evaluation of a New Intra-operative Probe and a Mini Gamma Camera

University Hospital, Strasbourg, France2 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2006年6月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
25
试验地点
2
主要终点
The day before the surgery: Lymphoscintigraphy in a Nuclear Medicine Department

研究概览

简要总结

This project consists on the realization followed by the clinical validation of two medical instruments dedicated to the precise sentinel lymph nodes identification and localization in the case of breast cancer: an intra operative probe and an operative mini gamma camera. The sentinel lymph node technique, based on the propagation of cancer cells in the lymphatic system, allows a better evaluation of tumor staging, prognosis and therapeutic strategy determination. The goal of these instruments designed by physicians and physicists is to significantly improve the detection efficiency of the technique in order to reduce the false negative rate and then the recurrence risk, as well as the operative morbidity.Clinical oncologist surgeons and fundamental physics applied to medical imaging researchers are involved in this project. The clinical validation of the medical instruments will be organized in the Gynaecologic and Obstetric department of the Hospices Civils de Strasbourg with a series of 25 patients in the framework of a regular french protocol of clinical research.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Single Group
主要目的
Treatment
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

  • infiltrative breast cancer
  • no suspect axillary lymph node
  • no previous radiotherapy
  • no previous chemotherapy
  • no previous breast surgery

排除标准

  • 未提供

结局指标

主要结局

The day before the surgery: Lymphoscintigraphy in a Nuclear Medicine Department

The day of the surgery: Preoperative axillary area mapping with the operative gamma camera. Search of sentinel lymph nodes with the probe

Post operative axillary area imaging with the operative gamma camera.

次要结局

  • Depth of the sentinel lymph nodes by a ruler before their excisions.
  • Radioactivity of the sentinel lymph nodes after their excisions.

研究者

发起方
University Hospital, Strasbourg, France
申办方类型
Other

研究点 (2)

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