Magnetic Seed Localisation for Nonpalpable Breast Lesions

NCT ID: NCT03988777

Last Updated: 2019-06-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

192 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-09-10

Study Completion Date

2019-05-23

Brief Summary

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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, MagseedĀ® 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 MagseedĀ® localisation will be assessed and retrospectively compared to hooked-wire localisation.

Detailed Description

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Conditions

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Oncology Breast Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Study Groups

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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.

Preoperative localisation technique

Intervention Type DEVICE

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.

Preoperative localisation technique

Intervention Type DEVICE

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

Interventions

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Preoperative localisation technique

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

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

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

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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KU Leuven

OTHER

Sponsor Role collaborator

Universitaire Ziekenhuizen KU Leuven

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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University Hospitals Leuven

Leuven, , Belgium

Site Status

Countries

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Belgium

Other Identifiers

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S61864

Identifier Type: -

Identifier Source: org_study_id

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