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

Abstract

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.

• Authors: A Piñero-Madrona, J A Torró-Richart, J M de León-Carrillo, G de Castro-Parga, J Navarro-Cecilia, F Domínguez-Cunchillos, J M Román-Santamaría, C Fuster-Diana, R Pardo-García, Grupo de Estudios Senológicos de la Sociedad Española de Patologia Mamaria (SESPM)
• Journal: 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) Vol. 41 Issue 8 Pg. 991-7 (Aug 2015) ISSN: 1532-2157 [Electronic] England
• PMID: 25997792 (Publication Type: Comparative Study, Journal Article, Multicenter Study)
• Copyright: Copyright © 2015 Elsevier Ltd. All rights reserved.

Chemical References

• superparamagnetic blood pool agent
• Ferrosoferric Oxide

Topics

• Adult
• Aged
• Aged, 80 and over
• Axilla
• Breast Neoplasms (diagnosis, metabolism, secondary)
• Female
• Ferrosoferric Oxide (pharmacokinetics)
• Humans
• Lymph Nodes (metabolism, pathology)
• Lymphatic Metastasis
• Middle Aged
• Retrospective Studies
• Sentinel Lymph Node Biopsy (methods)