NCT03988777

Magnetic Seed Localisation for Nonpalpable Breast Lesions

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 192 (actual)
• Sponsor: Universitaire Ziekenhuizen KU Leuven · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Oncology
• Breast Cancer

Interventions

Type	Name	Description
DEVICE	Preoperative localisation technique	Impalpable breast lesions are preoperatively localised, either with hooked-wire (retrospective study) or Magseed (prospective study)

Timeline

• Start date: 2018-09-10
• Primary completion: 2019-03-29
• Completion: 2019-05-23
• First posted: 2019-06-17
• Last updated: 2019-06-17

Locations

1 site across 1 country: Belgium

Regulatory

• FDA-regulated device study