Magnetic Seed Localisation for Nonpalpable Breast Lesions

Study Overview
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Brief Summary
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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.

Official Title
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Magnetic Seed Localisation for Nonpalpable Breast Lesions: a Combined Retrospective and Prospective Analysis

Conditions
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Oncology, Breast Cancer

Intervention / Treatment
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* Device: Preoperative localisation technique


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Breast conserving surgery with preoperative localisation Minimum 18 years old

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Prospective Magseed<br>This cohort includes patients with an impalpable breast lesion that are scheduled for breast conserving surgery with Magseed localisation after September 2018. Their data will be prospectively collected and analysed. | Device: Preoperative localisation technique<br>* Impalpable breast lesions are preoperatively localised, either with hooked-wire (retrospective study) or Magseed (prospective study)<br>|
| Retrospective hooked-wire<br>This cohort includes patients with an impalpable breast lesion that were scheduled for breast conserving surgery with hooked-wire before September 2018. Their data will be retrospectively collected and analysed. | Device: Preoperative localisation technique<br>* Impalpable breast lesions are preoperatively localised, either with hooked-wire (retrospective study) or Magseed (prospective study)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participant with device-related adverse events |  | Up to three weeks after surgical treatment | 
| Total breast volume resected during breast conserving surgery |  | Up to three weeks after surgical treatment | 
| Number of participants with positive surgical margins as assessed by pathological examination of the specimen |  | Up to three weeks after surgical treatment | 
| Re-operation rate due to positive surgical margins |  | Up to three weeks after surgical treatment | 
| Surgeon satisfaction based on a questionnaire | 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. | After surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Breast cancer, Nonpalpable breast lesions, Hooked-wire localisation, Magnetic seed localisation