Magnetic Seed Localisation for Nonpalpable Breast Lesions

Completed

• Conditions: Breast Cancer; Oncology
• Interventions: Device: Preoperative localisation technique

• Registration Number: NCT03988777
• Lead Sponsor: Universitaire Ziekenhuizen KU Leuven

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-09-10
• Primary Completion: 2019-03-29
• Status Verified: 2019-05
• Study Completion: 2019-05-23
• Study First Submitted: 2019-05-29
• Study First Submitted QC: 2019-06-14
• Last Update Submitted: 2019-06-14
• Study First Posted: 2019-06-17
• Last Update Posted: 2019-06-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 192

Inclusion Criteria

• Breast conserving surgery with preoperative localisation
• Minimum 18 years old

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Prospective Magseed	Preoperative localisation technique	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.
Retrospective hooked-wire	Preoperative localisation technique	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.

Primary Outcome Measures

Name	Time	Method
Total breast volume resected during breast conserving surgery	Up to three weeks after surgical treatment
Number of participant with device-related adverse events	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	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.

Trial Locations

Locations (1)

University Hospitals Leuven; 🇧🇪 Leuven, Belgium