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| Name | Class |
|---|---|
| Canadian Breast Cancer Foundation | OTHER |
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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).
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| radioguided seed localization for nonpalpable breast cancers | Procedure | radio-labelled (I-125) titanium seed inserted via needle into nonpalpable breast lesion and gamma probe used to guide surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Compare the number of positive margins following excision of the nonpalpable breast tumours for the two different surgical techniques | immediate post-operative pathology results |
| Measure | Description | Time Frame |
|---|---|---|
| Compare procedure times, complications and volume of tissue excised for both techniques | intra-operative |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Peter J Lovrics, MD | McMaster University | Principal Investigator |
| Mary Townsend | Administrator for Research Programs, McMaster University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St. Joseph's Healthcare | Hamilton | Ontario | L8N 4A6 | Canada | ||
| Juravinski Cancer Centre |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22794705 | Derived | Reedijk M, Hodgson N, Gohla G, Boylan C, Goldsmith CH, Foster G, Cornacchi SD, McCready D, Lovrics PJ. A prospective study of tumor and technical factors associated with positive margins in breast-conservation therapy for nonpalpable malignancy. Am J Surg. 2012 Sep;204(3):263-8. doi: 10.1016/j.amjsurg.2012.03.007. Epub 2012 Jul 12. | |
| 21533657 |
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| ID | Term |
|---|---|
| D000071960 | Breast Carcinoma In Situ |
| ID | Term |
|---|---|
| D002278 | Carcinoma in Situ |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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| Hamilton |
| Ontario |
| L8V 5C2 |
| Canada |
| Princess Margaret Hospital | Toronto | Ontario | M5G 2M9 | Canada |
| Lovrics PJ, Goldsmith CH, Hodgson N, McCready D, Gohla G, Boylan C, Cornacchi S, Reedijk M. A multicentered, randomized, controlled trial comparing radioguided seed localization to standard wire localization for nonpalpable, invasive and in situ breast carcinomas. Ann Surg Oncol. 2011 Nov;18(12):3407-14. doi: 10.1245/s10434-011-1699-y. Epub 2011 Apr 30. |
| D009369 | Neoplasms |
| D001943 | Breast Neoplasms |
| D009371 | Neoplasms by Site |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |