RFID trial: localization of non-palpable breast lesions using radiofrequency identification tags or wire

Breast cancer is the most frequently diagnosed cancer and the leading cause of cancer death in women with 58,500 new cases in France in 2018. Approximately 50% of breast cancers are discovered at an early stage in mainly young patients and for whom conservative surgery is indicated. Intraoperative localization of non-palpable breast lesions is generally accomplished using a hook wire to mark the area of concern under ultrasound or stereotactic localization.

However, this technique has several drawbacks. Indeed, it appears as a relatively painful and anxious procedure for patients. It can also be a source of difficulty for the surgeon, because only the entry point is visible: the orientation and length of the wire are assessed on a control image. Moreover, it leads to a time coordination obligation between radiologists and surgeons since the localization device cannot remain in place for more than 24 h. Finally, because the end of the hook wire comes out at one end of the breast and goes through the skin it can be associated with a risk of infection, breakage, accidental exposure to blood or wire dislodgement.

During the last decades, other localization techniques have been studied as alternatives to hook wire [1]. None of these alternatives has been able to prove its superiority compared to hook wire, which remains the gold-standard. A wire-free breast lesion system using miniature radiofrequency identification (RFID) tags appears as an interesting alternative (LOCalizer™ with CE marking and FDA labelling). It is a radio-opaque tag that emits a radiofrequency signal when excited at a specified wavelength. It is carried by a 12-gauge coaxial needle and can be positioned under ultrasound or stereotactic guidance. A receiver that registers the RFID number is available for radiologists and handheld reader displays the distance to the tag in millimeters (up to 6 cm) for surgeons. This technique aims to improve patient comfort and surgical comfort by increasing localization accuracy. Moreover, radiologists would no longer be dependent on the surgical schedule. The oblong shape of the tag should reduce the risk of accidental exposure to blood, and material breakage. Nevertheless, the cost of this technique remains significantly higher than the hook wire. Acceptance and changes in practices by radiologists and surgeons are necessary.

To date, few articles address radiofrequency localization, and most studies are of recent publication [2‐5]. The main publications on radiofrequency localization deal with a small number of patients, without comparison to the gold-standard, and primarily assess safety, acceptance, and technique performance [2, 4, 6]. Only one American retrospective study implies a large number of patients (n = 503) and compares RFID localization qualities to the gold-standard [3]. They concluded that RFID tag localization is a possible alternative to hook wire and should be considered for non-palpable breast lesions. To date, no study has looked at the interest of the technique in terms of patient comfort. We therefore propose a study to assess the interest of introducing the RFID localization technique at the Jean Perrin comprehensive cancer center.

Preoperative breast localization using hook wire remains the gold standard technique. But it has restrictive time requirements for surgeons and radiologists. It also causes patient discomfort and anxiety. Thus, this has led to finding and developing wire free alternatives. In this study, we focus on the wire free localization using RFID tag. Wazir et al. have shown that wireless localization using RFID is an effective and time-efficient alternative to wire guided localization [4]. These RFID tags appear as a great alternative since they could improve patients comfort and reduce the restrictive scheduling requirements imposed by the gold-standard localization.

Moreover, the RFID study is the first study in France which specifically assesses the interest of the RFID localization in terms of patients comfort. Patient comfort is one of the key elements to take into consideration when managing patients in oncology and new technologies such as RFID tags could improve it.

However, the RFID technique has a major drawback: it remains more expensive than the hook wire technique. Nonetheless, in the long term, a generalization of the technique in comprehensive cancer centers and hospitals could allow a cost reduction.