Literature DB >> 27469121

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 Cox1, Scott Russell1, Vanessa Prowler2, Ebonie Carter1, Abby Beard2, Ankur Mehindru1, Peter Blumencranz3, Kathleen Allen3, Michael Portillo3, Pat Whitworth4, Kristi Funk5, Julie Barone6, Denise Norton6, Jerome Schroeder6, Alice Police7, Erin Lin7, Freddie Combs7, Freya Schnabel8, Hildegard Toth8, Jiyon Lee8, Beth Anglin9, Minh Nguyen9, Lynn Canavan10, Alison Laidley11, Mary Jane Warden12, Ronald Prati13, Jeff King1, Steven C Shivers14.   

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.

Entities:  

Mesh:

Year:  2016        PMID: 27469121     DOI: 10.1245/s10434-016-5405-y

Source DB:  PubMed          Journal:  Ann Surg Oncol        ISSN: 1068-9265            Impact factor:   5.344


  13 in total

Review 1.  Update of the American Society of Breast Surgeons Toolbox to address the lumpectomy reoperation epidemic.

Authors:  Maureen P McEvoy; Jeffrey Landercasper; Himani R Naik; Sheldon Feldman
Journal:  Gland Surg       Date:  2018-12

Review 2.  Paradigm Shifts in Breast Care Delivery: Impact of Imaging in a Multidisciplinary Environment.

Authors:  Savitri Krishnamurthy; Therese Bevers; Henry M Kuerer; Benjamin Smith; Wei Tse Yang
Journal:  AJR Am J Roentgenol       Date:  2016-12-08       Impact factor: 3.959

Review 3.  Innovations in image-guided preoperative breast lesion localization.

Authors:  Ellen Cheang; Richard Ha; Cynthia M Thornton; Victoria L Mango
Journal:  Br J Radiol       Date:  2018-02-06       Impact factor: 3.039

4.  Preoperative radioactive seed localization of nonpalpable soft tissue masses: an established localization technique with a new application.

Authors:  Hillary W Garner; Joseph M Bestic; Jeffrey J Peterson; Steven Attia; Daniel E Wessell
Journal:  Skeletal Radiol       Date:  2016-11-24       Impact factor: 2.199

5.  Doppler Ultrasound-Visible SignalMark Microspheres are Better Identified than HydroMARK® Clips in a Simulated Intraoperative Setting in Breast and Lung Tissue.

Authors:  Rachel K Voss; Erin P Ward; Haydee Ojeda-Fournier; Sarah L Blair
Journal:  Ann Surg Oncol       Date:  2018-09-03       Impact factor: 5.344

6.  Wireless Breast Localization Using Radio-frequency Identification Tags: The First Reported European Experience in Breast Cancer.

Authors:  Umar Wazir; Salim Tayeh; Nicholas Perry; Michael Michell; Anmol Malhotra; Kefah Mokbel
Journal:  In Vivo       Date:  2020 Jan-Feb       Impact factor: 2.155

7.  Preoperative Localization of Breast MRI Lesions: MRI-guided Marker Placement With Radioactive Seed Localization as an Alternative to MRI-guided Wire Localization.

Authors:  Nicole Saphier; Jessica Kondraciuk; Elizabeth Morris; Blanca Bernard-Davila; Victoria Mango
Journal:  J Breast Imaging       Date:  2020-04-23

Review 8.  Intraoperative Localization Using an Implanted Radar Reflector Facilitates Resection of Non-Palpable Trunk and Extremity Sarcoma.

Authors:  Kristy Kummerow Broman; David Joyce; Odion Binitie; G Douglas Letson; Ricardo J Gonzalez; Junsung Choi; John E Mullinax
Journal:  Ann Surg Oncol       Date:  2020-10-18       Impact factor: 4.339

9.  Early budget impact analysis on magnetic seed localization for non-palpable breast cancer surgery.

Authors:  Melanie Lindenberg; Anne van Beek; Valesca Retèl; Frederieke van Duijnhoven; Wim van Harten
Journal:  PLoS One       Date:  2020-05-13       Impact factor: 3.240

10.  Reflector-Guided Localisation of Non-Palpable Breast Lesions: A Prospective Evaluation of the SAVI SCOUT® System.

Authors:  Umar Wazir; Iham Kasem; Michael J Michell; Tamara Suaris; David Evans; Anmol Malhotra; Kefah Mokbel
Journal:  Cancers (Basel)       Date:  2021-05-17       Impact factor: 6.639

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