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临床试验/NCT00225927
NCT00225927已完成不适用

A Prospective, Randomized, Controlled Trial of Radioguided Seed Localization Versus Standard Needle Localization of Nonpalpable Breast Cancers

McMaster University6 个研究点 分布在 1 个国家目标入组 333 人开始时间: 2004年6月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
333
试验地点
6
主要终点
Compare the number of positive margins following excision of the nonpalpable breast tumours for the two different surgical techniques

研究概览

简要总结

The purpose of this study is to determine whether a new surgical technique (radioguided seed localization) for localizing nonpalpable breast tumours is better than the standard technique (needle localization).

详细描述

Most breast cancers are removed by partial mastectomy/lumpectomy. The most important factor in ensuring that the cancer does not return in the breast is to ensure that it is completely removed during surgery. Complete removal is dependent on having a rim of normal tissue (clear margin) surrounding the cancer. If the margin is positive, or the cancer recurs, more surgery or mastectomy is required. Approximately one third of breast cancers are detected by mammograms or ultrasounds and cannot be felt by patients or physicians. Accordingly, a localization technique is required to help the surgeon to find and remove the cancer. The current technique (needle localization) has a higher chance of having cancer cells at the margin. This is a study about a surgical technique. The objective of this comparison study is to determine whether a new technique (radioguided seed localization) is a better way to remove nonpalpable breast cancers. The main objective of this study is to determine if the new technique generates fewer positive margins compared to the standard technique. An improved technique would benefit thousands of women every year.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
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

  • Histologically confirmed invasive or in situ breast carcinoma
  • Nonpalpable breast tumour
  • Candidate for breast conserving surgery (BCS) based on clinical and radiologic evaluation

排除标准

  • Histological confirmation more than 3 months from enrollment
  • Pregnancy or lactation
  • Contraindication to BCS or patient requests mastectomy
  • Age less than 18 years
  • Male patient

结局指标

主要结局

Compare the number of positive margins following excision of the nonpalpable breast tumours for the two different surgical techniques

时间窗: immediate post-operative pathology results

次要结局

  • Compare procedure times, complications and volume of tissue excised for both techniques(intra-operative)

研究者

申办方类型
Other

研究点 (6)

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