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The existing approach to Sentinel lymph node biopsy (SLNB) is effective, with good sensitivity (95-97%) that enables the surgeon to detect almost all sentinel nodes. However, there are significant drawbacks and issues:
- For the patient: the exposure to radioactivity through use of radioisotopes; and the need to be admitted to hospital the night before the operation, which can result in increased pre-operative anxiety.
- For the surgeon: the exposure to radioactivity and the associated burden of regulated handling procedures for surgical items, including swabs; the highly directional nature of the gamma probe, so that nodes can be missed; the time decaying radioisotope signal which means that if operations are delayed the SLNB becomes more difficult, which has knock-on effects on workflow; and the reliance on the hospital’s nuclear medicine department, which removes an element of control from the surgeon.
- For the hospital: the burden placed on, and the requirement for, dedicated staff in the nuclear medicine department; the increasing regulatory burden associated with the use of radioisotopes (e.g. in Europe, the ARSAC and IRMER regulations are impacting on working practice); and the risk of scheduling
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SentiMAG™
The Endomagnetics solution is to use a magnetic dye – such as the commercially available and FDA approved MRI contrast agent, Feridex® – rather than the radioactive tracer and blue dye; and to use an ultrasensitive hand-held magnetic probe – the SentiMAG™ – rather than the gamma probe. By sensing even tiny amounts (typically <100 µg) of the clinically introduced magnetic nanoparticles, SentiMAG™ is easily able to locate the sentinel nodes. The magnetic signal is practically time-invariant, as it only decays through the natural process of metabolisation, which takes days. By contrast, uptake is rapid, with good signals being measured 5-10 minutes after injection. The magnetic dye may be administered by the surgeon, which, coupled with the rapid uptake into the nodes, means that full control of the procedure is delivered directly to the surgeon.
Fig. 1. The Endomagnetics solution – SentiMAG™
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