Magnetic Seed Localisation for Nonpalpable Breast Lesions

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03988777

Enrollment

192

Registered

2019-06-17

Start date

2018-09-10

Completion date

2019-05-23

Last updated

2019-06-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer, Oncology

Keywords

Breast cancer, Nonpalpable breast lesions, Hooked-wire localisation, Magnetic seed localisation

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.

Interventions

DEVICEPreoperative localisation technique

Impalpable breast lesions are preoperatively localised, either with hooked-wire (retrospective study) or Magseed (prospective study)

Study design

Observational model

COHORT

Time perspective

OTHER

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

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

Design outcomes

Primary

Measure	Time frame	Description
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.

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026