A Prospective, Randomized, Controlled Trial of Radioguided Seed Localization Versus Standard Needle Localization of Nonpalpable Breast Cancers
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.
Interventional
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Compare the number of positive margins following excision of the nonpalpable breast tumours for the two different surgical techniques
immediate post-operative pathology results
No
Peter J Lovrics, MD
Principal Investigator
McMaster University
Canada: Canadian Nuclear Safety Commission
2
NCT00225927
June 2004
June 2010
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