Trial Comparing Radioactive Seed Localization to Standard Procedure for Non-palpable Breast Cancers
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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).
| Condition | Intervention |
|---|---|
|
Breast Cancer Invasive Nos Stage 0 Breast Carcinoma |
Procedure: radioguided seed localization for nonpalpable breast cancers |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Prospective, Randomized, Controlled Trial of Radioguided Seed Localization Versus Standard Needle Localization of Nonpalpable Breast Cancers |
- Compare the number of positive margins following excision of the nonpalpable breast tumours for the two different surgical techniques [ Time Frame: immediate post-operative pathology results ] [ Designated as safety issue: No ]
- Compare procedure times, complications and volume of tissue excised for both techniques [ Time Frame: intra-operative ] [ Designated as safety issue: No ]
| Enrollment: | 333 |
| Study Start Date: | June 2004 |
| Study Completion Date: | June 2010 |
| Primary Completion Date: | March 2010 (Final data collection date for primary outcome measure) |
-
Procedure: radioguided seed localization for 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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Histologically confirmed invasive or in situ breast carcinoma
- Nonpalpable breast tumour
- Candidate for breast conserving surgery (BCS) based on clinical and radiologic evaluation
Exclusion Criteria:
- 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
Contacts and Locations| Canada, Ontario | |
| St. Joseph's Healthcare | |
| Hamilton, Ontario, Canada, L8N 4A6 | |
| Juravinski Cancer Centre | |
| Hamilton, Ontario, Canada, L8V 5C2 | |
| Princess Margaret Hospital | |
| Toronto, Ontario, Canada, M5G 2M9 | |
| Principal Investigator: | Peter J Lovrics, MD | McMaster University |
| Study Chair: | Mary Townsend | Administrator for Research Programs, McMaster University |
More Information
No publications provided by McMaster University
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Dr. Peter J. Lovrics, McMaster University |
| ClinicalTrials.gov Identifier: | NCT00225927 History of Changes |
| Other Study ID Numbers: | 2 |
| Study First Received: | September 16, 2005 |
| Last Updated: | February 28, 2011 |
| Health Authority: | Canada: Canadian Nuclear Safety Commission Canada: Ministry of Health & Long Term Care, Ontario |
Keywords provided by McMaster University:
|
invasive breast cancer in situ breast cancer radioguided seed localization |
nonpalpable tumour needle localization margin status |
Additional relevant MeSH terms:
|
Breast Neoplasms Carcinoma Carcinoma in Situ Neoplasms by Site Neoplasms |
Breast Diseases Skin Diseases Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type |
ClinicalTrials.gov processed this record on May 23, 2013