title: A Prospective, Single Arm, Multi-site, Clinical Evaluation of a Nonradioactive Surgical Guidance Technology for the Location of Nonpalpable Breast Lesions during Excision.
abstract: 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.
  
  
  
  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.
  
  
  
  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.
  
  
  
  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.
authors.affiliation: USF Breast Health Program, University of South Florida, Tampa, FL, USA.
authors.forename: Charles E
authors.initials: CE
authors.lastname: Cox
authors.affiliation: USF Breast Health Program, University of South Florida, Tampa, FL, USA.
authors.forename: Scott
authors.initials: S
authors.lastname: Russell
authors.affiliation: Department of Surgery, University of South Florida, Tampa, FL, USA.
authors.forename: Vanessa
authors.initials: V
authors.lastname: Prowler
authors.affiliation: USF Breast Health Program, University of South Florida, Tampa, FL, USA.
authors.forename: Ebonie
authors.initials: E
authors.lastname: Carter
authors.affiliation: Department of Surgery, University of South Florida, Tampa, FL, USA.
authors.forename: Abby
authors.initials: A
authors.lastname: Beard
authors.affiliation: USF Breast Health Program, University of South Florida, Tampa, FL, USA.
authors.forename: Ankur
authors.initials: A
authors.lastname: Mehindru
authors.affiliation: Morton Plant Hospital, Clearwater, FL, USA.
authors.forename: Peter
authors.initials: P
authors.lastname: Blumencranz
authors.affiliation: Morton Plant Hospital, Clearwater, FL, USA.
authors.forename: Kathleen
authors.initials: K
authors.lastname: Allen
authors.affiliation: Morton Plant Hospital, Clearwater, FL, USA.
authors.forename: Michael
authors.initials: M
authors.lastname: Portillo
authors.affiliation: Nashville Breast Center, Nashville, TN, USA.
authors.forename: Pat
authors.initials: P
authors.lastname: Whitworth
authors.affiliation: Pink Lotus Breast Center, Beverly Hills, CA, USA.
authors.forename: Kristi
authors.initials: K
authors.lastname: Funk
authors.affiliation: Cancer Centers of Colorado, Denver, CO, USA.
authors.forename: Julie
authors.initials: J
authors.lastname: Barone
authors.affiliation: Cancer Centers of Colorado, Denver, CO, USA.
authors.forename: Denise
authors.initials: D
authors.lastname: Norton
authors.affiliation: Cancer Centers of Colorado, Denver, CO, USA.
authors.forename: Jerome
authors.initials: J
authors.lastname: Schroeder
authors.affiliation: UC Irvine Health Pacific Breast Care Center, Costa Mesa, CA, USA.
authors.forename: Alice
authors.initials: A
authors.lastname: Police
authors.affiliation: UC Irvine Health Pacific Breast Care Center, Costa Mesa, CA, USA.
authors.forename: Erin
authors.initials: E
authors.lastname: Lin
authors.affiliation: UC Irvine Health Pacific Breast Care Center, Costa Mesa, CA, USA.
authors.forename: Freddie
authors.initials: F
authors.lastname: Combs
authors.affiliation: NYU Langone Medical Center, New York, NY, USA.
authors.forename: Freya
authors.initials: F
authors.lastname: Schnabel
authors.affiliation: NYU Langone Medical Center, New York, NY, USA.
authors.forename: Hildegard
authors.initials: H
authors.lastname: Toth
authors.affiliation: NYU Langone Medical Center, New York, NY, USA.
authors.forename: Jiyon
authors.initials: J
authors.lastname: Lee
authors.affiliation: Medical Center of Plano Complete Breast Care, Plano, TX, USA.
authors.forename: Beth
authors.initials: B
authors.lastname: Anglin
authors.affiliation: Medical Center of Plano Complete Breast Care, Plano, TX, USA.
authors.forename: Minh
authors.initials: M
authors.lastname: Nguyen
authors.affiliation: Baylor Regional Medical Center at Plano, Plano, TX, USA.
authors.forename: Lynn
authors.initials: L
authors.lastname: Canavan
authors.affiliation: Texas Breast Specialists, Dallas, TX, USA.
authors.forename: Alison
authors.initials: A
authors.lastname: Laidley
authors.affiliation: Hackensack University Medical Center, Hackensack, NJ, USA.
authors.forename: Mary Jane
authors.initials: MJ
authors.lastname: Warden
authors.affiliation: Florida Hospital Tampa, Tampa, FL, USA.
authors.forename: Ronald
authors.initials: R
authors.lastname: Prati
authors.affiliation: USF Breast Health Program, University of South Florida, Tampa, FL, USA.
authors.forename: Jeff
authors.initials: J
authors.lastname: King
authors.affiliation: USF Breast Health Program, University of South Florida, Tampa, FL, USA. sshivers@health.usf.edu.
authors.forename: Steven C
authors.initials: SC
authors.lastname: Shivers
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001943:Breast Neoplasms / Q000000981:diagnostic imaging* / Q000601:surgery*; D005260:Female; D006801:Humans; D008327:Mammography; D000072662:Margins of Excision; D008875:Middle Aged; D018365:Neoplasm, Residual; D010173:Palpation; D011446:Prospective Studies; D011825:Radar; D012086:Reoperation; D025321:Surgery, Computer-Assisted / Q000295:instrumentation / Q000379:methods*; D016217:Ultrasonography, Mammary