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OpenTrials
Completed

NCT Number: NCT03988777

Magnetic Seed Localisation for Nonpalpable Breast Lesions

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.

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Key information

Conditions

Oncology Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

University Hospitals Leuven

Leuven, 3000, Belgium

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Treatment and study plan

Preoperative localisation technique

Device

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

Primary outcomes

  1. Number of participant with device-related adverse events

    Time frame: Up to three weeks after surgical treatment

  2. Total breast volume resected during breast conserving surgery

    Time frame: Up to three weeks after surgical treatment

  3. Number of participants with positive surgical margins as assessed by pathological examination of the specimen

    Time frame: Up to three weeks after surgical treatment

  4. Re-operation rate due to positive surgical margins

    Time frame: Up to three weeks after surgical treatment

  5. Surgeon satisfaction based on a questionnaire

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Universitaire Ziekenhuizen KU Leuven

Other

Collaborators

  • KU Leuven

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jun 17, 2019
Registry last updated
Jun 17, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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