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Microchipping the breast: an effective new technology for localizing non-palpable breast lesions for surgery

  • Maggie L. DiNomeEmail author
  • Amy M. Kusske
  • Deanna J. Attai
  • Cheryce P. Fischer
  • Anne C. Hoyt
Clinical trial

Abstract

Purpose

Use of a wire to localize a non-palpable breast lesion for surgery is standard but archaic. We sought to evaluate a new radiofrequency localization system (RFLS) as an effective, non-radioactive alternative to the wire.

Methods

Patients who required surgical excision of a non-palpable breast lesion were consented for the study. Patients underwent localization with a radiofrequency Tag and surgical removal guided by the handheld LOCalizer probe. The primary study endpoint was successful placement and retrieval of the Tag, and secondary endpoints included marker migration; days prior to surgery of Tag insertion; patient, radiologist, and surgeon experience; distance of Tag from skin; and positive margin and re-excision rates for cancer.

Results

Fifty patients had successful placement and retrieval of the radiofrequency Tag. Likert questionnaire data revealed that most patients thought the procedure went smoothly and was easier than expected. Radiologists and surgeons thought that the Tag was as reliable as the wire. Of the 33 patients who had surgery for in situ or invasive cancer, one had a positive margin on final pathology (3%) and two underwent re-excision (6%).

Conclusions

Data from this pilot study suggest that the RFLS is an effective localization system for non-palpable breast lesions intended for surgical removal. Unlike most other technologies, the LOCalizer probe detects distance from the Tag, and this unique feature may have contributed to the low positive margin rate seen in this study. The RFLS appears to offer advantages over current localization procedures and should be explored as an alternative to wire. ClinicalTrials.gov Identifier: NCT03202472.

Keywords

Radiofrequency Tag Breast surgery Wire-free localization 

Abbreviations

RFLS

Radiofrequency identification localization system

WL

Wire localization

RSL

Radioactive seed localization

RFID

Radiofrequency identification

FDA

Food and Drug Administration

Notes

Compliance with ethical standards

Conflict of interest

All the authors declare that they have no conflicts of interest.

Ethical approval

All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards.

Informed consent

Informed consent was obtained from all individual participants included in the study.

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Copyright information

© Springer Science+Business Media, LLC, part of Springer Nature 2019

Authors and Affiliations

  1. 1.Department of SurgeryUniversity of California Los AngelesLos AngelesUSA
  2. 2.Department of Radiologic SciencesUniversity of California Los AngelesSanta MonicaUSA

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