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Open Access 01-06-2016 | Clinical trial

The Nordic SentiMag trial: a comparison of super paramagnetic iron oxide (SPIO) nanoparticles versus Tc⁹⁹ and patent blue in the detection of sentinel node (SN) in patients with breast cancer and a meta-analysis of earlier studies

Authors: Andreas Karakatsanis, Peer Michael Christiansen, Lone Fischer, Christina Hedin, Lida Pistioli, Malin Sund, Nils Ryegaard Rasmussen, Hjørdis Jørnsgård, Daniel Tegnelius, Staffan Eriksson, Kosmas Daskalakis, Fredrik Wärnberg, Christos J. Markopoulos, Leif Bergkvist

Published in: Breast Cancer Research and Treatment | Issue 2/2016

Abstract

The aim of the study is to compare the efficacy of SPIO as a tracer in sentinel node biopsy (SNB) in breast cancer with Tc and patent blue in a multicentre prospective study and perform a meta-analysis of all published studies. It also aims to follow skin discoloration after SPIO injection and describe when and how it resolves. Totally 206 patients with early breast cancer were recruited. Tc and patent blue were administered in standard fashion. Patients were injected with SPIO (Sienna+) preoperatively. SNB was performed and detection rates were recorded for both methods. Skin discoloration was followed and documented postoperatively. Data extraction and subsequent meta-analysis of all previous studies were also performed. SN detection rates were similar between standard technique succeeded and SPIO both per patient (97.1 vs. 97.6 %, p = 0.76) as well as per node (91.3 vs. 93.3 %, p = 0.34), something which was not affected by the presence of malignancy. Concordance rates were also consistently high (98.0 % per patient and 95.9 % per node). Discoloring was present in 35.5 % of patients postoperatively, almost exclusively in breast conservation. It fades slowly and is still detectable in 8.6 % of patients after 15 months. Meta-analysis depicted similar detection rates (p = 0.71) and concordance rates (p = 0.82) per patient. However, it seems that SPIO is characterized by higher nodal retrieval (p < 0.001). SPIO is an effective method for the detection of SN in patients with breast cancer. It is comparable to the standard technique and seems to simplify logistics. Potential skin discoloration is something of consideration in patients planned for breast conservation.

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Title: The Nordic SentiMag trial: a comparison of super paramagnetic iron oxide (SPIO) nanoparticles versus Tc99 and patent blue in the detection of sentinel node (SN) in patients with breast cancer and a meta-analysis of earlier studies
Authors: Andreas Karakatsanis
Peer Michael Christiansen
Lone Fischer
Christina Hedin
Lida Pistioli
Malin Sund
Nils Ryegaard Rasmussen
Hjørdis Jørnsgård
Daniel Tegnelius
Staffan Eriksson
Kosmas Daskalakis
Fredrik Wärnberg
Christos J. Markopoulos
Leif Bergkvist
Publication date: 01-06-2016
Publisher: Springer US
Published in: Breast Cancer Research and Treatment / Issue 2/2016
Print ISSN: 0167-6806
Electronic ISSN: 1573-7217
DOI: https://doi.org/10.1007/s10549-016-3809-9

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