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Surgeon and Radiologist Evaluation of Electromagnetic Chip Localization for Benign and Malignant Breast Lesions

  • Breast Oncology
  • Published:
Annals of Surgical Oncology Aims and scope Submit manuscript

Abstract

Background

SmartClipTM is a food and drug administration-approved, electromagnetic chip (EMC) localization system that provides three-dimensional navigation for the excision of soft tissue lesions. The purpose of this study was to analyze the accuracy and feasibility of EMC radiologic and surgical localization for benign and malignant breast lesions.

Patients and Methods

An institutional review board-approved, single institution, prospective study from October 2020 to September 2022 of 38 women undergoing breast conserving surgery with EMC localization of a single lesion > 5 mm on mammogram (MMG) or ultrasound (US) imaging. Surveys from performing breast radiologists and breast surgeons were collected after image-guided localization and surgical excision.

Results

Seventy-six survey responses from nine radiologists and four surgeons were received. The deployment needle and EMC were highly visible in 86.8% and 76.3% of procedures, respectively. There was no difficulty in deployment for 92.1% of procedures. The EMC was in the correct location on postdeployment MMG in 97.4% of cases. Three instances of EMC migration occurred, one 1 cm from target lesion. The targeted mass and EMC were within the surgical specimen in 97.4% of cases. On specimen radiograph, 39.5% of the EMCs were 0–1 mm from the center of the target lesion, 18.4% were within 2–4 mm, and 23.7% were within 5–10 mm. Mean operating room time for all cases was 65 min. One case required US to localize the target due to console malfunction.

Conclusion

There was successful EMC deployment by radiologists with accurate visualization and successful surgical excision in most cases. The EnVisioTM SmartClipTM system is a reproducible and accurate localization method for benign and malignant breast lesions.

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Authors and Affiliations

  1. H. Lee Moffitt Cancer Center and Research Institute, Tampa, FL, USA

    Nicholas T. Champion MD, Blaise Mooney MD, Youngchul Kim PhD, Junmin Whiting PhD, Weihong Sun MD, MS, John Kiluk MD, Brian Czerniecki MD, PhD, Susan Hoover MD & Marie Catherine Lee MD

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  1. Nicholas T. Champion MD
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Correspondence to Nicholas T. Champion MD.

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Disclosure

This study was funded by Elucent Medical, Inc. Dr. MC Lee is a paid consultant for Elucent Medical. Dr. B Mooney was a paid consultant for Elucent Medical prior to this study.

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Champion, N.T., Mooney, B., Kim, Y. et al. Surgeon and Radiologist Evaluation of Electromagnetic Chip Localization for Benign and Malignant Breast Lesions. Ann Surg Oncol 30, 7081–7090 (2023). https://doi.org/10.1245/s10434-023-13976-5

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