Sentinel node biopsy using a magnetic tracer versus standard technique: the SentiMAG Multicentre Trial

Michael Douek (Corresponding Author), Joost Klaase, Ian Monypenny, Ashutosh Kothari, Katalin Zechmeister, Douglas Brown, Lynda Wyld, Philip Drew, Hans Garmo, Olorunsola Agbaje, Quentin Pankhurst, Bauke Anninga, Maarten Grootendorst, Bennie Ten Haken, Margaret A Hall-Craggs, Arnie Purushotham, Sarah Pinder, SentiMAG Trialists Group

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Abstract

BACKGROUND: The SentiMAG Multicentre Trial evaluated a new magnetic technique for sentinel lymph node biopsy (SLNB) against the standard (radioisotope and blue dye or radioisotope alone). The magnetic technique does not use radiation and provides both a color change (brown dye) and a handheld probe for node localization. The primary end point of this trial was defined as the proportion of sentinel nodes detected with each technique (identification rate).

METHODS: A total of 160 women with breast cancer scheduled for SLNB, who were clinically and radiologically node negative, were recruited from seven centers in the United Kingdom and The Netherlands. SLNB was undertaken after administration of both the magnetic and standard tracers (radioisotope with or without blue dye).

RESULTS: A total of 170 SLNB procedures were undertaken on 161 patients, and 1 patient was excluded, leaving 160 patients for further analysis. The identification rate was 95.0 % (152 of 160) with the standard technique and 94.4 % (151 of 160) with the magnetic technique (0.6 % difference; 95 % upper confidence limit 4.4 %; 6.9 % discordance). Of the 22 % (35 of 160) of patients with lymph node involvement, 16 % (25 of 160) had at least 1 macrometastasis, and 6 % (10 of 160) had at least a micrometastasis. Another 2.5 % (4 of 160) had isolated tumor cells. Of 404 lymph nodes removed, 297 (74 %) were true sentinel nodes. The lymph node retrieval rate was 2.5 nodes per patient overall, 1.9 nodes per patient with the standard technique, and 2.0 nodes per patient with the magnetic technique.

CONCLUSIONS: The magnetic technique is a feasible technique for SLNB, with an identification rate that is not inferior to the standard technique.

Original languageEnglish
Pages (from-to)1237-1245
Number of pages9
JournalAnnals of Surgical Oncology
Volume21
Issue number4
Early online date10 Dec 2013
DOIs
Publication statusPublished - Apr 2014

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Douek, M., Klaase, J., Monypenny, I., Kothari, A., Zechmeister, K., Brown, D., Wyld, L., Drew, P., Garmo, H., Agbaje, O., Pankhurst, Q., Anninga, B., Grootendorst, M., Ten Haken, B., Hall-Craggs, M. A., Purushotham, A., Pinder, S., & SentiMAG Trialists Group (2014). Sentinel node biopsy using a magnetic tracer versus standard technique: the SentiMAG Multicentre Trial. Annals of Surgical Oncology, 21(4), 1237-1245. https://doi.org/10.1245/s10434-013-3379-6