Magnetic Seed Localisation for Nonpalpable Breast Lesions

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

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.

Study Overview

• Status: Completed
• Conditions: Breast Cancer; Oncology
• Intervention / Treatment: Device: Preoperative localisation technique

• Study Type: Observational
• Enrollment (Actual): 192

Contacts and Locations

Study Locations

• Belgium
  • Leuven, Belgium, 3000
    • University Hospitals Leuven

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Study population includes women (18+) with an impalpable breast lesion suitable for breast conserving surgery.

Description

Inclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Other

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Prospective Magseed; 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; Impalpable breast lesions are preoperatively localised, either with hooked-wire (retrospective study) or Magseed (prospective study)
Retrospective hooked-wire; 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; Impalpable breast lesions are preoperatively localised, either with hooked-wire (retrospective study) or Magseed (prospective study)

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Universitaire Ziekenhuizen KU Leuven
• Collaborators: KU Leuven

Study record dates

Study Major Dates

• Study Start (Actual): September 10, 2018
• Primary Completion (Actual): March 29, 2019
• Study Completion (Actual): May 23, 2019

Study Registration Dates

• First Submitted: May 29, 2019
• First Submitted That Met QC Criteria: June 14, 2019
• First Posted (Actual): June 17, 2019

Study Record Updates

• Last Update Posted (Actual): June 17, 2019
• Last Update Submitted That Met QC Criteria: June 14, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Keywords: Breast cancer; Nonpalpable breast lesions; Hooked-wire localisation; Magnetic seed localisation
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: S61864

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes