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

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.

Image-Guided Localization Techniques for Metastatic Axillary Lymph Nodes in Breast Cancer; What Radiologists Should Know

“…In a randomized clinical trial by Bloomquist et al, RSL-arm demonstrated a better outcome in terms of intra-procedure pain compared to wire guide localization. The overall suitability of the procedure was evaluated as very good to excellent in 85% of RSL patients compared with 44% of wire guide localization patients [ 79 ].…”

“…Despite the small dose of radiations and low radioactive risk for the operators [ 58 ], the procedure is not authorized in some countries [ 79 ] and requires complex radiation safety procedure and a strict timeframe for removal. One study showed that dropping of semen into the surgical bed can occur during LN removal, even if with a very low possibility.…”

“…This happens when the semen is placed at the edge of the LN [ 58 ]. An additional disadvantage related to the misplaced semen is the impossibility of repositioning the seed [ 79 ]. In these cases, the only resolving alternative is surgical removal.…”

“…Moreover, a signal reduction over time has been described in some cases of prolonged or interrupted chemotherapy. Despite a very low risk, emergency treatment with iodine is required in case of semen rupture to avoid damage to the thyroid gland [ 79 ].…”

“…In cases where more than one microchip is inserted inside the armpit, the microchip identification number allows them to be distinguished [ 79 ]. Although this is not an absolute contraindication as it rarely occurs, operators should be careful not to place tags within 20 mm of each other, as the reader may not distinguish between them [ 98 ].…”