The aim of the study was to evaluate potential equivalency of the SentiMag® technique for sentinel lymph node biopsy in comparison with the “gold standard” of using radiotracer 99mTc with or without blue dye.
The study ran from November 2012 to June 2013 at four major European hospitals and recruited 150 breast cancer patients.
The study was led by Dr Marc Thill (interview) at the Department of Gynaecology and Obstetrics, Breast Cancer Centre, Agaplesion Markus Hospital, Frankfurt, Germany.
Participating sites included the Department of Surgical Oncology, Medical University of Lublin, Poland, the Interdisciplinary Breast Centre, Kantonsspital Baden, Baden, Switzerland and the Breast Centre Bern, Engeriedspital, Lindenhofgruppe, Bern, Switzerland.
The results showed a detection rate per patient of 97.3% (146/150) for 99mTc vs. 98.0% (147/150) for Sienna+® with a similar average number of removed sentinel lymph nodes per patient and a higher per-patient malignancy detection rate for the Sienna+® tracer.
The results of the trial were published online in January 2014.