Update on Preoperative Breast Localization

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Key points

  • Preoperative same-day wire localization (WL) using mammography, ultrasound, MR imaging, and computed tomographic (CT) guidance aids surgical excision of nonpalpable breast lesions.

  • Non–wire localization devices (I125 RSL, SCOUT RADAR, MAGSEED, and RFID) may provide an alternative means to mark and aids surgical excision of nonpalpable breast lesions and axillary lymph nodes up to 5 to 30 days preoperatively under mammography, ultrasound, and CT guidance.

  • Non–wire deployment systems via MR

Current procedures

Conservative breast surgical treatment programs rely on image guidance devices and skills of the radiologist and surgeon. Table 1 summarizes various localization methods reviewed by Corsi and colleagues.8 They reported that because no single localization tool or technique proved better for achieving adequate SM, when advantages and disadvantages of each were taken into account, each multidisciplinary surgical team should adopt the most effective localization and margin assessment technique

Types of non–wire devices

Types of non–wire devices are compared in Fig. 5.

Nonradioactive non–wire devices: SCOUT, MAGSEED, and RFID

The nonradioactive non–wire devices are passive and contain no energy source. Nonradioactive device systems are not constrained by regulations for radioactive devices and therefore can be deployed in one facility and removed in another facility.

SCOUT RADAR device

SCOUT is a nonradioactive non–wire localization device that uses infrared light and radar technology. SCOUT was FDA cleared in August 2014 for localization of breast lesions. As of September 2016, SCOUT Radar has been used in more than 5000 patients in more than 75 US facilities.

The 12-mm SCOUT device is deployed via a 16-g needle introduced under imaging guidance 0 to 30 days before surgery. Retracting the release button, rather than pushing forward, to unsheathe the SCOUT, deploys the device.

MAGSEED device

The MAGSEED device was FDA 510(k) cleared in March 2016 for the localization of breast lesions up to 30 days before surgery. Nonresearch, clinical use of MAGSEED has been commercially available in the US since August 2016. Two clinical studies are ongoing, one for lesion localization (NCT03020888) and one for localization of axillary lymph nodes (NCT03038152). MAGSEED is a metal marker which contains iron particles. The dedicated Sentimag probe uses MAGSEED to generate an alternating magnetic

Radiofrequency identification tag

The FDA has approved implantation of radiofrequency tags in humans for the purposes of identification. RFID systems use radio waves to transfer information. A passive tag has no energy source and can communicate a range of information from one serial number to several pages of data. Pending FDA clearance, the 9-mm RFID tag can be deployed 0 to 30 days before surgery through a preloaded sterile 12-g needle similar to biopsy CLIP or RSL (see Fig. 3). When the patient is in the supine surgical

Future opportunities

Future opportunities for non–wire, nonradioactive localization devices require large-scale multi-institutional studies in the United States. Areas for investigation and development may include the following:

  • Longer-term placement in patients undergoing neoadjuvant treatment

  • Placement in suspicious axillary lymph nodes

  • MR-compatible needle introducers

  • Comprehensive cost-analysis comparison to include device cost, start-up costs, institutional cost of OR delays and cancellations, administrative costs

Summary

The radiologist plays an important role in detection, diagnosis, localization, pathologic correlation, and follow-up management of patients with breast cancer. The preoperative breast localization devices used by the radiologist and the refined definitions of negative SMs impact the multidisciplinary treatment of breast cancer. This article has reviewed the wire and non–wire tools available for image-guided preoperative localization. Non–wire devices provide the benefits of improved efficiency

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    Disclosure Statement: The author's hospital received research support from Hologic, Inc (IRB MH#2012.048 and MH#2014.036). The author's employer receives research support from Cianna Medical (IRB MH#2016.078). The author has served on a scientific advisory panel for Hologic and Cianna Medical.

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