A Prospective, Single Arm, Multi-site, Clinical Evaluation of a Nonradioactive Surgical Guidance Technology for the Location of Nonpalpable Breast Lesions during Excision
- 719 Downloads
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.
KeywordsExcisional Biopsy Breast Localization Wire Localization Surgical Guidance Nonpalpable Breast Lesion
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.
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.
- 9.National Quality Measures for Breast Centers. Quality performance you should measure. 2016. http://www.nqmbc.org/QualityPerformanceYouShouldMeasure.htm. Accessed 28 Jan 2016.
- 15.Cox CE, Garcia-Henriquez N, Glancy MJ, Whitworth P, Cox JM, Themar-Geck M, Prati R, Jung M, Russell S, Appleton K, King J, Shivers SC. Pilot study of a new nonradioactive surgical guidance technology for locating nonpalpable breast lesions. Ann Surg Oncol. 2016;23(6):1824–30. doi: 10.1245/s10434-015-5079-x.CrossRefPubMedGoogle Scholar