Endomagnetics has supported clinical trials with SentiMag® that indicate strong concurrence with the gamma probe technique.
To compare the efficacy of the SentiMag® method against current methods, early trials injected each patient with (a) Patent Blue optical tracer, (b) 99mTc radioactive tracer and (c) 2 ml of Endorem/Feridex® magnetic tracer. The sentinel nodes were localized using both a gamma probe and SentiMag®. A total of 53 patients were recruited and the results indicated an overall ex-vivo SLN detection rate for SentiMag® of 86%. However, the detection rate was 93% in patients who received Endorem/Feridex® more than 1 hour prior to surgery, indicating that Endorem/Feridex®, with its ~150 nanometer particle diameter, is slower to transit the lymphatic system.
With Sienna+™ having received European marketing authorization, a multi-site, pan-European trial was launched in January 2012 to establish statistical equivalence to the gamma-based SLNB technique using this new, optimally-sized tracer.
This section will be updated with additional trial results once available.