Ignite Creation Date:
2024-05-05 @ 12:02 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00225927
Status:
COMPLETED
Last Update Posted:
2011-03-02
First Post:
2005-09-16
Brief Title:
Trial Comparing Radioactive Seed Localization to Standard Procedure for Non-palpable Breast Cancers
Sponsor:
McMaster University
Organization:
McMaster University
Study Overview
Official Title:
A Prospective Randomized Controlled Trial of Radioguided Seed Localization Versus Standard Needle Localization of Nonpalpable Breast Cancers
Status:
COMPLETED
Status Verified Date:
2010-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
Detailed Description:
Most breast cancers are removed by partial mastectomylumpectomy 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None