Abstract P4-13-11: A new simplified cost-effective technique for localization of non-palpable breast lesions
Authors: Kaufman Cary S , Cross Michael J , Pierce Kelly A , Rajgopal Ujwala D , Rankin Katherine E , Sipe Whitney A , Lebovic Gail S 
Published: March 2020

Introduction: Standard wire localization has long been the standard of care to assist surgeons with locating and excising non-palpable breast lesions identified by imaging. Significant challenges include scheduling conflicts, delays in surgery, accuracy in targeting the lesion, wire displacement or migration, and overall inconvenience for patients, clinicians and facilities. In an attempt to address these challenges, a number of complex wireless approaches have emerged. However, they are costly and require the purchase of multiple pieces of capital equipment. Additionally, these wireless approaches lose the benefits of visual and tactile cues for the surgeon during excision. In this multi-centered pilot series, we report on a novel method of percutaneous localization that secures the target lesion, may be placed prior to the day of surgery and provides the surgeon with tactile guidance during dissection without the challenges of standard wire localization.

Methods: Following informed consent, 37 patients undergoing partial mastectomy or excisional biopsy were evaluated in a prospective manner. The localization device (PERL™ Hologic, Sunnyvale, CA) consists of a needle cannula with a handle deployment mechanism housing a sharp nitinol Ring. Following infiltration of local anesthetic in the skin and target region, the introducing needle was advanced into the breast under image guidance and the Ring was deployed and securely seated at or around the target. The Ring is attached to a highly flexible, suture-like tail emerging from the skin. When the Ring device was placed the day before surgery, the flexible tail external to the skin was coiled under an adhesive dressing allowing the patient to return to work or home. Confirmation of target localization was imaged by ultrasound, mammography and specimen x-ray. Procedure characteristics were noted at placement and surgical removal.

Results: 30 of 39 placements were performed by surgeons and 9 were placed by radiologists. All devices were placed under ultrasound guidance with an average placement time of 6 minutes. All deployments were successfully directed to the intended target without migration including those placed on a different day/time from the surgery. Localization using the Ring enabled 100% successful surgical targeting. There were no technical complications, infection or significant patient discomfort associated with placement or removal of the device. For the 36 lesions with a pre-operative cancer diagnosis, 35 (97%) had clear margins and one (3%) required re-excision for a positive DCIS margin.

Conclusions: Percutaneous Ring Localization (PERL™) is a novel approach to lesion localization in the breast that solves issues associated with standard wire localization. This multi-center experience demonstrates that PERL can be utilized to guide the excision of non-palpable lesions, provides visual and tactile cues during surgery, and avoids repeated intraoperative handling of expensive scanning devices. The Ring and flexible tail allow placement at a time and location separate from the surgery with minimal discomfort and without migration. This pilot series illustrates that PERL can provide a cost-effective solution to issues with wire localization using a familiar clinical platform. Further studies are warranted based on these results.

Results TableNumber of Lesions Targeted39Number of Patients Treated37Bilateral Lesions2PERL Placed by Surgeons30PERL Placed by Radiologists9Average Time to Place PERL6 minutesNumber of Cancers Localized36Final Cancer Margin Negative35Percent Re-excision (n=1)3%

Citation Format: Cary S Kaufman, Michael J Cross, Kelly A Pierce, Ujwala D Rajgopal, Katherine E Rankin, Whitney A Sipe, Gail S Lebovic. A new simplified cost-effective technique for localization of non-palpable breast lesions [abstract]. In: Proceedings of the 2019 San Antonio Breast Cancer Symposium; 2019 Dec 10-14; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2020;80(4 Suppl):Abstract nr P4-13-11.