Radiofrequency Chip for Localization of Non-Palpable Breast Lesions

Category Primary study
Registry of Trialsclinicaltrials.gov
Year 2018
As part of standard of care, participants will receive: an ultrasound (US) or mammographic guided localization; excisional breast surgery; and a follow‐up visit in breast surgery clinic. As part of the research protocol, participants will receive a RFID chip for the localization procedure and complete surveys. Part A of this project is for physician training to master the technique of RFID placement and retrieval. On the day of surgery prior to going to the operating room, all participants will have the RFID placed first to allow radiologists to become familiar with placement of the RFID localizer. Participants will then immediately undergo wire localization. Either ultrasound or mammogram guidance will be used for the localization at the discretion of the performing radiologist. Surgeons will use a reader to locate the RFID chip during surgery. The wire will be present in the event the area of concern cannot be adequately located with the reader. Participants, radiologists, surgeons, breast surgery and radiology staff will complete surveys. Part B of this project is a prospective trial to examine safety, efficacy, operating room utilization patterns, and satisfaction with RFID versus wire localization. Participants will be stratified based on technique of localization (either US guidance or mammographic guidance). Participants will then be randomized to receive either the wire or RFID localization. There will be four visits: one pre‐op breast surgery visit in which enrollment will occur, one radiology procedure visit for localization, one surgical visit, and one post‐operative visit. This is the same number of visits as standard of care. Participants, radiologists, surgeons, breast surgery and radiology staff will complete surveys.
Epistemonikos ID: 37da28b240be1de8f8c88898ee1267c008077761
First added on: May 21, 2024