A Multi-Center Prospective Evaluation of a Radiofrequency Identification Tag in the Localization of Nonpalpable Breast Lesions
Julie L. Barone, DO1, 2 ; Lawrence E. Goldberger, MD2 ; Jerome S. Schroeder, MD1 ; and Christine Dauphine, MD3
1. Saint Joseph Hospital Breast Care Center 1375 E 19th Ave, Denver, CO 80218 2. Sharp Memorial Hospital and Comprehensive Breast Care of San Diego, 3075 Health Center Drive San Diego CA 92123 3. Harbor-UCLA Medical Center 1000 W. Carson St. Box 25, Torrance, CA 90502
The purpose of this study was to evaluate the safety and efficacy of a radiofrequency identification (RFID) tag in the localization of nonpalpable breast lesions.
MATERIALS AND METHODS
Institutional Review Board approval was obtained at each of the two participating institutions prior to initiation of this study at each site. Consecutive adult patients undergoing excision of a nonpalpable breast lesion were approached to participate. Enrolled subjects underwent placement of an RFID tag on the same day as elective operative excision.
The implanted RFID tag is detected utilizing a handheld reader device placed over the skin. The sound emitted from the reader device increases in volume and pitch as the reader approaches the tag.
A hookwire was also placed in the initial patients at each study site and in cases where the RFID tags were placed under stereotactic guidance. The RFID tag was the primary method used by the operating surgeon to localize each lesion during excision, with the hookwire serving as backup in case of tag migration or failed localization. Patient data, including breast size and lesion location (quadrant of the breast, distance to areola, depth from the skin) were collected.
Successful localization and removal of the intended lesion were the primary outcomes measured. Potential complications such as tag migration and postoperative infection were also
recorded in order to assess safety.
Forty-six patients underwent placement of 47 RFID tags, 39 under ultrasound guidance and 8 with stereotactic guidance. Thirty-five patients had breast cancer, and 11 had benign lesions.
In all 47 excisions, the RFID tag was successfully localized by the reader at the level of the skin prior to incision, and the target lesion was visualized within the excised specimen. There were no localization failures and no postoperative infections.
Tag migration did not occur prior to incision, but in 13 cases, the tag slipped out of the lesion as it was being retracted to make the final cut along the deep surface of the specimen. Six cancer patients had positive margins, one of which ultimately underwent mastectomy due to patient choice.
The use of an RFID tag system is an effective and safe method of localization of nonpalpable breast lesions in this investigation. RFID localization of nonpalpable breast tumors for surgical excision may represent an alternative method to hookwire localization.