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Review
. 2023 Feb 12;15(4):1173.
doi: 10.3390/cancers15041173.

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

Maggie Banys-Paluchowski  1 , Thorsten Kühn  2 , Yazan Masannat  3 , Isabel Rubio  4 , Jana de Boniface  5   6 , Nina Ditsch  7 , Güldeniz Karadeniz Cakmak  8 , Andreas Karakatsanis  9   10 , Rajiv Dave  11 , Markus Hahn  12 , Shelley Potter  13 , Ashutosh Kothari  14 , Oreste Davide Gentilini  15 , Bahadir M Gulluoglu  16 , Michael Patrick Lux  17 , Marjolein Smidt  18 , Walter Paul Weber  19 , Bilge Aktas Sezen  20 , Natalia Krawczyk  21 , Steffi Hartmann  22 , Rosa Di Micco  15 , Sarah Nietz  23 , Francois Malherbe  24 , Neslihan Cabioglu  25 , Nuh Zafer Canturk  26 , Maria Luisa Gasparri  27   28   29 , Dawid Murawa  30 , James Harvey  31
Affiliations
Review

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

Maggie Banys-Paluchowski et al. Cancers (Basel). .

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

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Conflict of interest statement

Maggie Banys-Paluchowski has received honoraria for lectures and participation in advisory boards: Roche, Novartis, Pfizer, pfm, Eli Lilly, Onkowissen, Seagen, AstraZeneca, Eisai, AstraZeneca, Amgen, Samsung, MSD, GSK, Daiichi Sankyo, Gilead, Canon, Sirius Pintuition, and Pierre Fabre; and study support from Endomag, Mammotome, MeritMedical, Gilead, ExactSciences. Ash Kothari has received a research grant from Endomag and acts as PI of the respective study. Andreas Karakatsanis has received a research grant from Endomag; acts as PI of the respective study; and recieved honoraria from Pfizer and Resitu AB. Michael P. Lux received honoraria for lectures and advisory participation from Lilly, AstraZeneca, MSD, Roche, Novartis, Pfizer, Eisai, Exact Sciences, Daiichi-Sankyo, Grünenthal, Gilead, Pierre Fabre, PharmaMar, pfm, Samantree, and Endomag; travel expenses from AstraZeneca, Roche, and Pfizer; editorial board membership for medac. Francois Malherbe received honoraria and travel support from Sysmex, the local distributor of Magseed. Dawid Murawa received honoraria for lectures from Roche, Medtronic, Stryker, Mammotome, MDT—diagnostic green, GEM-Italy, Combat-Medical. Other authors declared no conflicts of interest.

Figures

Figure 1
Figure 1
Examples of commercially available localization devices (the depicted size does not correctly compare the different markers shown): (A) Magseed (5 × 1 mm); (B) Sirius Pintuition (5 × 1.65 mm); (C) SAVI SCOUT (12 × 1.6 mm); (D) LOCalizer (11 × 2 mm) [reprinted with permission of manufacturers 2022: Endomag, Sirius Medical, Merit Medical, Hologic].
Figure 2
Figure 2
(A,B) Control mammography after ultrasound-guided wire placement in a patient with an invasive breast cancer, NST, max. size 11 mm. (C) Specimen mammography.
Figure 3
Figure 3
Magseed detection system. (A) Multicentric invasive lobular cancer (distance between lesions 4.7 cm). Each lesion is marked with a Magseed. Magtrace (SPIO) is injected between the lesions. (B) Transcutaneous detection with the probe. Mark the lack of skin discoloration after a deep Magtrace injection. (C) Ex vivo signal of the specimen. Both Magseeds have maximum signal. Observe the brown tissue staining at the SPIO injection site that does not affect specimen radiography. (D) Specimen radiography depicting the lesions with Magseeds (red circles highlight the position of Magseed markers).
Figure 4
Figure 4
Sirius Pintuition system. (A) Ultrasound-guided placement of the marker (yellow arrow). (B) Intraoperative radiogram showing the marker in the center of the specimen. (C) Console used for detection in the OR showing 11 mm distance between probe tip and marker.
Figure 5
Figure 5
SAVI SCOUT system. (A) Control mammography after ultrasound-guided marker placement in a patient with an invasive breast cancer, NST, max. size: 12 mm. (B) Ultrasound of the marker and lesion. (C) Console used for detection in the operating room. (D) Intraoperative use of radar probe to guide excision.
Figure 6
Figure 6
LOCalizer system. (A) Control mammography after ultrasound-guided placement of two RFID markers (one of them is near the thoracic wall and therefore not visible on the mammogram). (B) Specimen radiogram confirming the excision of both markers and the lesion. (C) Intraoperative use of the radiofrequency probe to guide excision.
Figure 7
Figure 7
Ultrasound-guided excision of ductal carcinoma in situ with a preoperative placement of an US-visible marker. (A) Area of microcalcifications surrounding the US-visible marker seen on preoperative imaging. (B) Assessing marker before incision with IOUS with US-visible marker. (C) Specimen ultrasound after excision of the clip-marked area confirming marker removal. (D) Specimen radiograph to assess microcalcifications excised.
Figure 8
Figure 8
Carbon ink localization. (A) Intentional skin tattoo to mark the exact position of the lesion. (B,C) Intraoperative photos showing carbon ink in the tissue that will guide excision.
Figure 9
Figure 9
MELODY flow chart.
See this image and copyright information in PMC

References

    1. Schermers B., van Riet Y.E., Schipper R.J., Vrancken Peeters M.J., Voogd A.C., Nieuwenhuijzen G.A.P., Ten Haken B., Ruers T.J.M. Nationwide registry study on trends in localization techniques and reoperation rates in non-palpable ductal carcinoma in situ and invasive breast cancer. Br. J. Surg. 2021;109:53–60. doi: 10.1093/bjs/znab339. - DOI - PubMed
    1. Somasundaram S.K., Potter S., Elgammal S., Maxwell A.J., Sami A.S., Down S.K., Dave R.V., Harvey J. Impalpable breast lesion localisation, a logistical challenge: Results of the UK iBRA-NET national practice questionnaire. Breast Cancer Res. Treat. 2021;185:13–20. doi: 10.1007/s10549-020-05918-6. - DOI - PubMed
    1. Hirst A., Agha R.A., Rosin D., McCulloch P. How can we improve surgical research and innovation?: The IDEAL framework for action. Int. J. Surg. 2013;11:1038–1042. doi: 10.1016/j.ijsu.2013.09.016. - DOI - PubMed
    1. Kasem I., Mokbel K. Savi Scout(R) Radar Localisation of Non-palpable Breast Lesions: Systematic Review and Pooled Analysis of 842 Cases. Anticancer Res. 2020;40:3633–3643. doi: 10.21873/anticanres.14352. - DOI - PubMed
    1. Lowes S., Bell A., Milligan R., Amonkar S., Leaver A. Use of Hologic LOCalizer radiofrequency identification (RFID) tags to localise impalpable breast lesions and axillary nodes: Experience of the first 150 cases in a UK breast unit. Clin. Radiol. 2020;75:942–949. doi: 10.1016/j.crad.2020.08.014. - DOI - PubMed

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