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Axilla - Submitted Innovations

The below content has been supplied directly by innovators/industry and does not imply endorsement from iBRA-NET.

01

Magtrace is a lymphatic mapping agent that is injected into the breast for sentinel node biopsy procedures. Magtrace acts as a dual tracer – it is both detected magnetically by the probe and visually marks the node. This means that Magtrace can replace Technetium and blue dye with one single injection.    Unlike blue dyes or radioisotope, Magtrace has been developed to comprise of uniformly sized particles that are optimised for sentinel lymph node biopsies. The particles are small enough to allow for rapid transport to the axilla in minutes and large enough to be filtered by the first draining sentinel nodes.    Magtrace’s rapid migration, mechanical filtration by the sentinel nodes, non-marking of higher echelon nodes and not timing out for days means that the patient can be injected as little as 20 minutes before knife-to-skin, or many days ahead of surgery. This provides flexibility that no other mapping agent can offer, allowing the injection to be scheduled when it’s convenient and without delaying the operating list.    Magtrace is detected using the same Sentimag platform as Magseed, a small marker for lesion localisation, making it the world’s first and only non-radioactive platform that offers both seed localisation and sentinel node biopsy. Sentimag has been used in over 40,000 procedures around the world, offering surgeons greater accuracy and flexibility in the management of patients. Magtrace, previously known as Sienna+, features in several published, peer reviewed papers which prove its non-inferiority to the gold standard dual technique of radioactive tracer and blue dye.


References:

  • Karakatsanis, A., Christiansen, P., Fischer, L., Hedin, C., Pistioli, L., Sund, M., Rasmussen, N., Jørnsgård, H., Tegnelius, D., Eriksson, S., Daskalakis, K., Wärnberg, F., Markopoulos, C. and Bergkvist, L. (2016). 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. Breast Cancer Research and Treatment, 157(2), pp.281-294. PMID: 27117158.

  • Teshome, M., Wei, C., Hunt, K., Thompson, A., Rodriguez, K. and Mittendorf, E. (2016). Use of a Magnetic Tracer for Sentinel Lymph Node Detection in Early-Stage Breast Cancer Patients: A Meta-analysis. Annals of Surgical Oncology, 23(5), pp.1508-1514. PMID: 26893221.

02

The RD-210 offers a fast, standardised and quantified (CK19 mRNA cps/ul) molecular sentinel lymph node analysis which ensures no metastasis is left undiscovered. Results of whole lymph node analysis, rather than sampling, are available in as little as 20 mins for those wanting to perform intraoperative assessment or can equally be analysed post operatively to provide confidence in clinical decision making in an era of surgical and therapy de-escalation. The sum of all CK19 mRNA positivity or Total Tumour Load (TTL) has been shown in many studies to help to identify patients at risk of non-sentinel node involvement and to have prognostic indication. By analysing your sentinel lymph nodes with the RD-210 you can perform any required further surgical intervention in one procedure, reduce patient anxiety associated with waiting for nodal status and reduce false negatives associated with the limitations of traditional LN analysis. One Step Nucleic Acid Amplification has been approved by NICE since 2013 and is now CE marked for six other cancer entities outside of breast.

 

References:

  • Ohi Y et al. (2012): Whole sentinel lymph node analysis by a molecular assay predicts axillary node status in breast cancer. Br J Cancer. 107(8) : 1239 – 43.

  • Peg V et al. (2017): Role of total tumour load of sentinel lymph node on survival in early breast cancer patients. Breast. 2017 Feb 27; 33 : 8 – 13.