title: Pilot Study of a New Nonradioactive Surgical Guidance Technology for Locating Nonpalpable Breast Lesions.
abstract: The current technique for locating nonpalpable breast lesions is wire localization (WL). Radioactive seed localization and intraoperative ultrasound were developed to improve difficulties with WL. The SAVI SCOUT surgical guidance system was developed to improve these methods. The SCOUT system is a non-radioactive, FDA-cleared medical device that uses electromagnetic wave technology to provide real-time guidance during excisional breast procedures.
  
  
  
  Consenting patients underwent localization and excision using an implantable electromagnetic wave reflective device (reflector) and a detector handpiece with a console. Using image guidance, the reflector was placed up to 7 days before the surgical procedure. The primary end points of the study were successful reflector placement, localization, and retrieval. The secondary end points were percentage of clear margins, reexcision rates, days of placement before excision, and physician comparison with WL.
  
  
  
  This study analyzed 50 patients. The reflectors were placed under mammographic guidance (n = 18, 36 %) or ultrasound guidance (n = 32, 64 %). Of the 50 patients, 10 (20 %) underwent excisional biopsy and 40 (80 %) had a lumpectomy. The lesion and reflector were successfully removed in all 50 patients, and no adverse events occurred. Of the 41 patients who had in situ and/or invasive carcinoma identified, 38 (93 %) had clear margins and 3 (7 %) were recommended for reexcision.
  
  
  
  These data suggest that the SCOUT system is safe and effective for guiding the excision of nonpalpable breast lesions and a viable alternative to standard localization options. A larger prospective, multi-institution trial of SCOUT currently is underway to validate these findings.
authors: University of South Florida (USF) Breast Health Program, USF Morsani College of Medicine, Tampa, FL, USA.
authors: Charles E
authors: CE
authors: Cox
authors: University of South Florida (USF) Breast Health Program, USF Morsani College of Medicine, Tampa, FL, USA.
authors: Norbert
authors: N
authors: Garcia-Henriquez
authors: University of South Florida (USF) Breast Health Program, USF Morsani College of Medicine, Tampa, FL, USA.
authors: M Jordan
authors: MJ
authors: Glancy
authors: Nashville Breast Center, Nashville, TN, USA.
authors: Pat
authors: P
authors: Whitworth
authors: Tampa Bay Breast Care Specialists, Tampa, FL, USA.
authors: John M
authors: JM
authors: Cox
authors: The Breast Care Center at Florida Hospital Tampa, Tampa, FL, USA.
authors: Melissa
authors: M
authors: Themar-Geck
authors: The Breast Care Center at Florida Hospital Tampa, Tampa, FL, USA.
authors: Ronald
authors: R
authors: Prati
authors: University of South Florida (USF) Breast Health Program, USF Morsani College of Medicine, Tampa, FL, USA.
authors: Michelle
authors: M
authors: Jung
authors: University of South Florida (USF) Breast Health Program, USF Morsani College of Medicine, Tampa, FL, USA.
authors: Scott
authors: S
authors: Russell
authors: Nashville Breast Center, Nashville, TN, USA.
authors: Kristie
authors: K
authors: Appleton
authors: University of South Florida (USF) Breast Health Program, USF Morsani College of Medicine, Tampa, FL, USA.
authors: Jeff
authors: J
authors: King
authors: University of South Florida (USF) Breast Health Program, USF Morsani College of Medicine, Tampa, FL, USA. sshivers@health.usf.edu.
authors: Steven C
authors: SC
authors: Shivers
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001943:Breast Neoplasms / Q000000981:diagnostic imaging / Q000473:pathology* / Q000601:surgery; D002285:Carcinoma, Intraductal, Noninfiltrating / Q000000981:diagnostic imaging / Q000473:pathology* / Q000601:surgery; D060733:Electromagnetic Radiation; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008327:Mammography; D015412:Mastectomy, Segmental; D008875:Middle Aged; D009361:Neoplasm Invasiveness; D009366:Neoplasm Seeding; D010865:Pilot Projects; D011379:Prognosis; D025321:Surgery, Computer-Assisted / Q000379:methods*; D016217:Ultrasonography, Mammary; D055815:Young Adult