The aim of this study is to compare the efficacy of the Sentimag localization system and its tracer Magtrace, superparamagnetic iron oxide nanoparticles, as a tracer in sentinel node biopsy in breast cancer with Tc99 in a single-center prospective study. The other part of the study will be the implantation of the smallest non-radioactive seed, Magseed, in the non-palpable breast cancer lesions. Another part of the study will be the implantation of Magseed in the positive axillary lymph nodes in patients diagnosed with clinically positive lymph nodes that will receive neoadjuvant systemic therapy.
Age range
18 Years
Sex
ALL
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The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
Accuracy of Magseed placement
Timeframe: During the surgical procedure
Surgeon-rated ease of detected lymph node localization and removal
Timeframe: During the surgical procedure
Number of nodes retrieved within the surgical specimen containing the Magseed
Timeframe: During the surgical procedure
Surgeon-rated ease of detected labeled lesion localization and removal
Timeframe: During the surgical procedure
Transcutaneous detection rate
Timeframe: During the surgical procedure
Incidence of adverse events
Timeframe: Up to 6 weeks post-procedure