Magnetic Seed Localisation for Nonpalpable Breast Lesions: a Combined Retrospective and Prospective Analysis
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Oncology
- Sponsor
- Universitaire Ziekenhuizen KU Leuven
- Enrollment
- 192
- Locations
- 1
- Primary Endpoint
- Number of participants with positive surgical margins as assessed by pathological examination of the specimen
- Status
- Completed
- Last Updated
- 6 years ago
Overview
Brief Summary
Screening programs and advances in imaging have led to more breast lesions being diagnosed at an impalpable stage. Multiple localisation techniques for nonpalpable breast lesions have been developed during the past decades. Specifically, several alternatives to the golden standard hooked-wire technique have become available, of which magnetic seed localisation is one of the newest approaches. Since September 2018, Magseed® localisation is the standard of care for localising impalpable breast lesions in UZ Leuven. In this study, the oncological safety, the clinical safety and surgeon satisfaction of Magseed® localisation will be assessed and retrospectively compared to hooked-wire localisation.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Breast conserving surgery with preoperative localisation
- •Minimum 18 years old
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Number of participants with positive surgical margins as assessed by pathological examination of the specimen
Time Frame: Up to three weeks after surgical treatment
Re-operation rate due to positive surgical margins
Time Frame: Up to three weeks after surgical treatment
Surgeon satisfaction based on a questionnaire
Time Frame: After surgery
After surgery, the surgeon will be asked to describe the magnetic seed procedure, choosing between 'easier than hooked-wire' or 'more challenging than hooked-wire'. Moreover, the surgeon wil have the chance to add additional remarks or experiences with this new technique.
Number of participant with device-related adverse events
Time Frame: Up to three weeks after surgical treatment
Total breast volume resected during breast conserving surgery
Time Frame: Up to three weeks after surgical treatment