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

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

来源：Annals of Surgical Oncology, 2016, 23(10): 3168-3174.

DOI：10.1245/s10434-016-5405-y

This study was a multicenter evaluation of the SAVI SCOUTA (R) 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 SCOUTA (R) reflectors placed up to 7 days before surgery, and placement was confirmed by mammography or ultrasonography. Implanted reflectors were detected by the SCOUTA (R) handpiece and console. Presence of the reflector in the excised surgical specimen was confirmed radiographically, and specimens were sent for routine pathology.
SCOUTA (R) 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.
SCOUTA (R) 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.

• 出版日期2016-10