Magnetic Seed Localisation for Nonpalpable Breast Lesions

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03988777
• Other study ID #: S61864
• Status: Completed
• Start date: September 10, 2018
• Est. completion date: May 23, 2019

Study information

• Verified date: May 2019
• Source: Universitaire Ziekenhuizen Leuven
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 192
• Est. completion date: May 23, 2019
• Est. primary completion date: March 29, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Breast conserving surgery with preoperative localisation

• Minimum 18 years old

Related Conditions & MeSH terms

• Breast Cancer
• Oncology

Intervention

Device:
• Preoperative localisation technique
Impalpable breast lesions are preoperatively localised, either with hooked-wire (retrospective study) or Magseed (prospective study)

Locations

Country	Name	City	State
Belgium	University Hospitals Leuven	Leuven

Sponsors (2)

Lead Sponsor	Collaborator
Universitaire Ziekenhuizen Leuven	KU Leuven

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participant with device-related adverse events		Up to three weeks after surgical treatment
Primary	Total breast volume resected during breast conserving surgery		Up to three weeks after surgical treatment
Primary	Number of participants with positive surgical margins as assessed by pathological examination of the specimen		Up to three weeks after surgical treatment
Primary	Re-operation rate due to positive surgical margins		Up to three weeks after surgical treatment
Primary	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