Effectiveness of Sentimag technology (Magseed and Magtrace localization) compared to traditional care for the management of early breast cancer: a systematic review protocol.

[OBJECTIVE] This systematic review aims to evaluate the effectiveness, safety, and patient- and surgeon-related outcomes of the Sentimag platform (Magseed and Magtrace) as alternatives to traditional localization techniques in the surgical management of early breast cancer.

[INTRODUCTION] Magseed and Magtrace are magnetic localization technologies increasingly used to replace traditional wire-guided and radioisotope techniques for tumor and sentinel lymph node localization in breast-conserving surgery. While the technology offers several theoretical advantages, current evidence is primarily observational, and high-certainty comparative data are limited.

[ELIGIBILITY CRITERIA] This review will include studies involving adult patients with impalpable breast cancer undergoing breast-conserving surgery using Magseed/Magtrace for surgical localization. Eligible study designs include randomized controlled trials, quasi-experimental, and cohort and description studies. Comparators will include hook wire and/or radioisotope +/- blue dye localization.

[METHODS] A comprehensive search will be conducted across PubMed, Embase, CINAHL, Cochrane CENTRAL, Scopus, and gray literature sources. Study selection, critical appraisal, data extraction, and data synthesis will be conducted by 2 independent reviewers in line with JBI methodology. Outcomes of interest include localization success, re-excision rate, resection volume, complication rates, patient and surgeon-reported outcomes, sentinel lymph node detection rate, and sentinel lymph node yield. Meta-analysis will be performed, where appropriate, using random-effects modeling. The Grading of Recommendations, Assessment, Development and Evaluation (GRADE) approach will be applied to assess certainty of evidence, and a Summary of Findings will be provided.

[REVIEW REGISTRATION] PROSPERO CRD420251069569.