Superparamagnetic iron oxide as a tracer for sentinel node biopsy in breast cancer: A comparative non-inferiority study.

Autor: Piñero-Madrona A; Department of Surgery, 'Virgen de la Arrixaca' University Hospital, 30120 Murcia, Spain. Electronic address: pineromadrona@gmail.com., Torró-Richart JA; Department of Surgery, 'Lluís Alcanyís' Hospital, Xàtiva, Valencia, Spain., de León-Carrillo JM; Breast Unit, 'Virgen del Rocío' University Hospital, Sevilla, Spain., de Castro-Parga G; Breast Unit, University Hospital Complex of Vigo, Vigo, Spain., Navarro-Cecilia J; Breast Pathology Unit, Hospital Complex of Jaén, Jaén, Spain., Domínguez-Cunchillos F; Department of Surgery, Hospital Complex of Navarra, Pamplona, Spain., Román-Santamaría JM; Breast Unit, University Clinic Hospital 'San Carlos', Madrid, Spain., Fuster-Diana C; Breast Unit, University General Hospital, Valencia, Spain., Pardo-García R; Breast Unit, Department of Surgery, University Hospital of Ciudad Real, Ciudad Real, Spain.
Jazyk: angličtina
Zdroj: European journal of surgical oncology : the journal of the European Society of Surgical Oncology and the British Association of Surgical Oncology [Eur J Surg Oncol] 2015 Aug; Vol. 41 (8), pp. 991-7. Date of Electronic Publication: 2015 May 12.
DOI: 10.1016/j.ejso.2015.04.017
Abstrakt: Aims: The gold standard for detection of Sentinel Lymph Nodes (SLN) is a combined radioisotope and blue dye breast injection, using a gamma probe (GP). A new, non-radioactive method was developed, using a tracer (Sienna+(®)) of superparamagnetic iron oxide (SPIO) nanoparticles and a manual magnetometer (SentiMag(®)) (SM). The IMAGINE study was designed to show the non-inferiority of SM compared to GP, for the detection of SLN in breast cancer patients with SLN biopsy indication.
Methods: From November 2013 to June 2014, 181 patients were recruited, and 321 nodes were excised and assessed ex-vivo. Readings from both SM and GP devices were recorded during transcutaneous, intraoperative, and ex-vivo detection attempts.
Results: At the patient level, ex-vivo detection rates (primary variable) with SM and GP were 97.8% and 98.3% (concordance rate 99.4%). Transcutaneous and intraoperative detection rates were 95.5% vs 97.2%, and 97.2% vs 97.8% for SM and GP respectively (concordance rates > 97%). At the node level, intraoperative and ex-vivo detection rates were 92.5% vs 89.3% and 91.0% vs 86.3% for SM and GP respectively. In all cases the non-inferiority of SM compared to SM was shown by ruling out a predefined non-inferiority margin of 5%.
Conclusions: Our study showed the non-inferiority of SM as compared to GP. Moreover, the ex-vivo and intraoperative detection rates at the node level were slightly higher with SM.
(Copyright © 2015 Elsevier Ltd. All rights reserved.)
Databáze: MEDLINE
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