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Clinical Results

The Sentimag® and Sienna+® tracer were developed in the clinic with direct input and feedback from surgeons during the design and prototyping process.  Since it was launched at the end of 2012, the system has been used to treat over 5,000 patients and has produced a strong base of clinical results that confirms its safety and efficacy in diagnosing and treating breast cancer. Clinical studies and trials involving over 1,000 patients across 12 European countries have demonstrated clinical equivalence to the standard of care for SLNB – either Technetium (99mTc) alone or the combination technique (99mTc and blue dye) [1-6].

 

Summarised results
Technique / Parameter*Sentimag®

Standard technique

Detection rate

     97%               97%
Concordance                       98%
Malignancy detection rate      95%               93%

Malignancy concordance

                       98%
Mean number of nodes       1.9                1.8

*All parameters calculated on a per-patient basis

 

References

[1] Douek et al. (2014): Sentinel node biopsy using a magnetic tracer vs. standard technique: The SentiMAG Multicentre Trial. Ann Surg Oncol; Vol 21(4): 1237 – 45.

[2] Thill et al. (2014): The Central-European SentiMag study: Sentinel lymph node biopsy with superparamagnetic iron oxide (SPIO) vs. radioisotope. Breast; Vol 23(2): 175-9.

[3] Rubio et al. (2015): The superparamagnetic iron oxide is equivalent to the Tc99 radiotracer method for identifying the sentinel lymph node in breast cancer. Eur J Surg Oncol; Vol 41(1):46-51.

[4] Piñero-Madrona et al. (2015): Superparamagnetic iron oxide as a tracer for sentinel node biopsy in breast cancer: a comparative non-inferiority study.  Eur J Surg Oncol; in press.

[5] Houpeau et al. (2014): Résultats de l’étude SENTIMAG évaluant un traceur magnétique pour l’identification du ganglion sentinelle (GS) dans le cancer du sein. Talk presented at SFSPM 2014.

[6] Ghilli et al. (2014): Italian multicentre study regarding sentinel node biopsy with superparamagnetic iron oxide versus radioisotope. Poster P153 presented at EBCC-9 2014.

Magnetic Sentinel lymph node localisation

Magnetic SLNB procedure

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