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Eur J Surg Oncol. 2015 Aug;41(8):991-7. doi: 10.1016/j.ejso.2015.04.017. Epub 2015 May 12.

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

Author information

1
Department of Surgery, "Virgen de la Arrixaca" University Hospital, 30120 Murcia, Spain. Electronic address: pineromadrona@gmail.com.
2
Department of Surgery, "Lluís Alcanyís" Hospital, Xàtiva, Valencia, Spain.
3
Breast Unit, "Virgen del Rocío" University Hospital, Sevilla, Spain.
4
Breast Unit, University Hospital Complex of Vigo, Vigo, Spain.
5
Breast Pathology Unit, Hospital Complex of Jaén, Jaén, Spain.
6
Department of Surgery, Hospital Complex of Navarra, Pamplona, Spain.
7
Breast Unit, University Clinic Hospital "San Carlos", Madrid, Spain.
8
Breast Unit, University General Hospital, Valencia, Spain.
9
Breast Unit, Department of Surgery, University Hospital of Ciudad Real, Ciudad Real, Spain.

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.

KEYWORDS:

Invasive breast cancer; SentiMag(®); Sentinel lymph node biopsy; Sienna+(®); Superparamagnetic iron oxide (SPIO)

PMID:
25997792
DOI:
10.1016/j.ejso.2015.04.017
[Indexed for MEDLINE]

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