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Annals of Surgical Oncology

, Volume 23, Issue 10, pp 3168–3174 | Cite as

A Prospective, Single Arm, Multi-site, Clinical Evaluation of a Nonradioactive Surgical Guidance Technology for the Location of Nonpalpable Breast Lesions during Excision

  • Charles E. Cox
  • Scott Russell
  • Vanessa Prowler
  • Ebonie Carter
  • Abby Beard
  • Ankur Mehindru
  • Peter Blumencranz
  • Kathleen Allen
  • Michael Portillo
  • Pat Whitworth
  • Kristi Funk
  • Julie Barone
  • Denise Norton
  • Jerome Schroeder
  • Alice Police
  • Erin Lin
  • Freddie Combs
  • Freya Schnabel
  • Hildegard Toth
  • Jiyon Lee
  • Beth Anglin
  • Minh Nguyen
  • Lynn Canavan
  • Alison Laidley
  • Mary Jane Warden
  • Ronald Prati
  • Jeff King
  • Steven C. ShiversEmail author
Breast Oncology

Abstract

Objectives

This study was a multicenter evaluation of the SAVI SCOUT® breast localization and surgical guidance system using micro-impulse radar technology for the removal of nonpalpable breast lesions. The study was designed to validate the results of a recent 50-patient pilot study in a larger multi-institution trial. The primary endpoints were the rates of successful reflector placement, localization, and removal.

Methods

This multicenter, prospective trial enrolled patients scheduled to have excisional biopsy or breast-conserving surgery of a nonpalpable breast lesion. From March to November 2015, 154 patients were consented and evaluated by 20 radiologists and 16 surgeons at 11 participating centers. Patients had SCOUT® reflectors placed up to 7 days before surgery, and placement was confirmed by mammography or ultrasonography. Implanted reflectors were detected by the SCOUT® handpiece and console. Presence of the reflector in the excised surgical specimen was confirmed radiographically, and specimens were sent for routine pathology.

Results

SCOUT® reflectors were successfully placed in 153 of 154 patients. In one case, the reflector was placed at a distance from the target that required a wire to be placed. All 154 lesions and reflectors were successfully removed during surgery. For 101 patients with a preoperative diagnosis of cancer, 86 (85.1 %) had clear margins, and 17 (16.8 %) patients required margin reexcision.

Conclusions

SCOUT® provides a reliable and effective alternative method for the localization and surgical excision of nonpalpable breast lesions using no wires or radioactive materials, with excellent patient, radiologist, and surgeon acceptance.

Keywords

Excisional Biopsy Breast Localization Wire Localization Surgical Guidance Nonpalpable Breast Lesion 
These keywords were added by machine and not by the authors. This process is experimental and the keywords may be updated as the learning algorithm improves.

Notes

Acknowledgments

This study was supported in part by an endowment from the Joy McCann Foundation. The clinical trial was funded by a grant from Cianna Medical, Inc.

Disclosure

Peter Blumencranz, MD and Charles Cox, MD are on the speakers’ bureau for the device manufacturer, Cianna Medical. Dr. Cox is also a consultant for Cianna Medical for the development of SAVI SCOUT. And, Dr. Cox is the PI of the current study sponsored by Cianna Medical. All other authors have nothing to disclose.

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Copyright information

© Society of Surgical Oncology 2016

Authors and Affiliations

  • Charles E. Cox
    • 1
  • Scott Russell
    • 1
  • Vanessa Prowler
    • 2
  • Ebonie Carter
    • 1
  • Abby Beard
    • 2
  • Ankur Mehindru
    • 1
  • Peter Blumencranz
    • 3
  • Kathleen Allen
    • 3
  • Michael Portillo
    • 3
  • Pat Whitworth
    • 4
  • Kristi Funk
    • 5
  • Julie Barone
    • 6
  • Denise Norton
    • 6
  • Jerome Schroeder
    • 6
  • Alice Police
    • 7
  • Erin Lin
    • 7
  • Freddie Combs
    • 7
  • Freya Schnabel
    • 8
  • Hildegard Toth
    • 8
  • Jiyon Lee
    • 8
  • Beth Anglin
    • 9
  • Minh Nguyen
    • 9
  • Lynn Canavan
    • 10
  • Alison Laidley
    • 11
  • Mary Jane Warden
    • 12
  • Ronald Prati
    • 13
  • Jeff King
    • 1
  • Steven C. Shivers
    • 1
    Email author
  1. 1.USF Breast Health ProgramUniversity of South FloridaTampaUSA
  2. 2.Department of SurgeryUniversity of South FloridaTampaUSA
  3. 3.Morton Plant HospitalClearwaterUSA
  4. 4.Nashville Breast CenterNashvilleUSA
  5. 5.Pink Lotus Breast CenterBeverly HillsUSA
  6. 6.Cancer Centers of ColoradoDenverUSA
  7. 7.UC Irvine Health Pacific Breast Care CenterCosta MesaUSA
  8. 8.NYU Langone Medical CenterNew YorkUSA
  9. 9.Medical Center of Plano Complete Breast CarePlanoUSA
  10. 10.Baylor Regional Medical Center at PlanoPlanoUSA
  11. 11.Texas Breast SpecialistsDallasUSA
  12. 12.Hackensack University Medical CenterHackensackUSA
  13. 13.Florida Hospital TampaTampaUSA

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