Localization Techniques for Non-Palpable Breast Lesions: Current Status, Knowledge Gaps, and Rationale for the MELODY Study (EUBREAST-4/iBRA-NET, NCT 05559411)

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Most breast cancers are small and can be treated using breast-conserving surgery. Since these tumors are non-palpable, they require a localization step that helps the surgeon to decide which tissue needs to be removed. The oldest localization technique is a guidewire placed into the tumor before surgery, usually using ultrasound or mammography. Afterwards, the surgeon removes the tissue around the wire tip. However, this technique has several disadvantages: it can cause the patient discomfort, requires a radiologist or another professional specialized in breast diagnostics to perform the procedure shortly before surgery, and 15–20% of patients need a second surgery to completely remove the tumor. Therefore, new techniques have been developed but most of them have not yet been examined in large, prospective, multicenter studies. In this review, we discuss all available techniques and present the MELODY study that will investigate their safety, with a focus on patient, surgeon, and radiologist preference.
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Simple Summary:

Most breast cancers are small and can be treated using breast-conserving surgery. Since these tumors are non-palpable, they require a localization step that helps the surgeon to
decide which tissue needs to be removed. The oldest localization technique is a guidewire placed
into the tumor before surgery, usually using ultrasound or mammography. Afterwards, the surgeon
removes the tissue around the wire tip. However, this technique has several disadvantages: it can
cause the patient discomfort, requires a radiologist or another professional specialized in breast diagnostics to perform the procedure shortly before surgery, and 15–20% of patients need a second
surgery to completely remove the tumor. Therefore, new techniques have been developed but most
of them have not yet been examined in large, prospective, multicenter studies. In this review, we
discuss all available techniques and present the MELODY study that will investigate their safety,
with a focus on patient, surgeon, and radiologist preference.

Abstract:

Background: Surgical excision of a non-palpable breast lesion requires a localization step.
Among available techniques, wire-guided localization (WGL) is most commonly used. Other techniques (radioactive, magnetic, radar or radiofrequency-based, and intraoperative ultrasound) have
been developed in the last two decades with the aim of improving outcomes and logistics. Methods:
We performed a systematic review on localization techniques for non-palpable breast cancer. Results: For most techniques, oncological outcomes such as lesion identification and clear margin rate
seem either comparable with or better than for WGL, but evidence is limited to small cohort studies
for some of the devices. Intraoperative ultrasound is associated with significantly higher negative
margin rates in meta-analyses of randomized clinical trials (RCTs). Radioactive techniques were
studied in several RCTs and are non-inferior to WGL. Smaller studies show higher patient preference towards wire-free localization, but little is known about surgeons’ and radiologists’ attitudes
towards these techniques. Conclusions: Large studies with an additional focus on patient, surgeon,
and radiologist preference are necessary. This review aims to present the rationale for the MELODY
(NCT05559411) study and to enable standardization of outcome measures for future studies.

Keywords:

breast cancer; localization technique; non-palpable lesion; intraoperative ultrasound;
wire-guided localization; magnetic seed; radioactive seed; radar reflector; radiofrequency identification tag

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