Endomagnetics was founded on initial clinical developments with SentiMag® that indicated a strong concurrence with the standard of care in sentinel lymph node localisation.
In 2012, Endomagnetics supported a larger clinical trial at seven major hospital sites in the UK and The Netherlands with 160 patients. The trial was co-sponsored by King’s College London (KCL) and Guy’s & St Thomas’ NHS Foundation Trust, and was adopted by the UK Clinical Research Network. The trial was designed to establish the clinical equivalence of Sienna+® and the SentiMag® to the combination technique (99mTc and blue dye), and it completed recruitment in Q4 2012.
The results of the trial were presented by lead surgeon, Mr. Michael Douek (KCL), at the 14th Annual Meeting of the American Society of Breast Surgeons (ASBS 2013) in Chicago on May 4th, 2013. The online proceedings (PDF link) noted that the proportion of successful procedures with the magnetic technique was 94% (151/160) versus 95% (152/160) for the standard technique, confirming that the magnetic technique is non-inferior.
Using 99mTc and/or blue dye as the gold standard, the SLN identification rate was 91% (146/160) for the magnetic technique, and 90% (144/160) for radioisotope alone. Lymph node retrieval rate was 2.5 nodes per patient overall, with 1.8 nodes/patient with the standard technique and 2.0 nodes/patient with SentiMag/Sienna+. The abstract concluded that “The magnetic technique is a feasible technique for SLNB with a high sentinel node identification rate. This trial is practice changing, particularly for those surgeons utilizing blue dye alone, for SLNB.”
Publications and further clinical trials are underway, and details will be published here as available.