A Piñero-Madrona1, J A Torró-Richart2, J M de León-Carrillo3, G de Castro-Parga4, J Navarro-Cecilia5, F Domínguez-Cunchillos6, J M Román-Santamaría7, C Fuster-Diana8, R Pardo-García9. 1. Department of Surgery, "Virgen de la Arrixaca" University Hospital, 30120 Murcia, Spain. Electronic address: pineromadrona@gmail.com. 2. Department of Surgery, "Lluís Alcanyís" Hospital, Xàtiva, Valencia, Spain. 3. Breast Unit, "Virgen del Rocío" University Hospital, Sevilla, Spain. 4. Breast Unit, University Hospital Complex of Vigo, Vigo, Spain. 5. Breast Pathology Unit, Hospital Complex of Jaén, Jaén, Spain. 6. Department of Surgery, Hospital Complex of Navarra, Pamplona, Spain. 7. Breast Unit, University Clinic Hospital "San Carlos", Madrid, Spain. 8. Breast Unit, University General Hospital, Valencia, Spain. 9. Breast Unit, Department of Surgery, University Hospital of Ciudad Real, Ciudad Real, Spain.
Abstract
AIMS: The gold standard for detection of Sentinel Lymph Nodes (SLN) is a combined radioisotope and blue dye breast injection, using a gamma probe (GP). A new, non-radioactive method was developed, using a tracer (Sienna+(®)) of superparamagnetic iron oxide (SPIO) nanoparticles and a manual magnetometer (SentiMag(®)) (SM). The IMAGINE study was designed to show the non-inferiority of SM compared to GP, for the detection of SLN in breast cancer patients with SLN biopsy indication. METHODS: From November 2013 to June 2014, 181 patients were recruited, and 321 nodes were excised and assessed ex-vivo. Readings from both SM and GP devices were recorded during transcutaneous, intraoperative, and ex-vivo detection attempts. RESULTS: At the patient level, ex-vivo detection rates (primary variable) with SM and GP were 97.8% and 98.3% (concordance rate 99.4%). Transcutaneous and intraoperative detection rates were 95.5% vs 97.2%, and 97.2% vs 97.8% for SM and GP respectively (concordance rates > 97%). At the node level, intraoperative and ex-vivo detection rates were 92.5% vs 89.3% and 91.0% vs 86.3% for SM and GP respectively. In all cases the non-inferiority of SM compared to SM was shown by ruling out a predefined non-inferiority margin of 5%. CONCLUSIONS: Our study showed the non-inferiority of SM as compared to GP. Moreover, the ex-vivo and intraoperative detection rates at the node level were slightly higher with SM.
AIMS: The gold standard for detection of Sentinel Lymph Nodes (SLN) is a combined radioisotope and blue dye breast injection, using a gamma probe (GP). A new, non-radioactive method was developed, using a tracer (Sienna+(®)) of superparamagnetic iron oxide (SPIO) nanoparticles and a manual magnetometer (SentiMag(®)) (SM). The IMAGINE study was designed to show the non-inferiority of SM compared to GP, for the detection of SLN in breast cancerpatients with SLN biopsy indication. METHODS: From November 2013 to June 2014, 181 patients were recruited, and 321 nodes were excised and assessed ex-vivo. Readings from both SM and GP devices were recorded during transcutaneous, intraoperative, and ex-vivo detection attempts. RESULTS: At the patient level, ex-vivo detection rates (primary variable) with SM and GP were 97.8% and 98.3% (concordance rate 99.4%). Transcutaneous and intraoperative detection rates were 95.5% vs 97.2%, and 97.2% vs 97.8% for SM and GP respectively (concordance rates > 97%). At the node level, intraoperative and ex-vivo detection rates were 92.5% vs 89.3% and 91.0% vs 86.3% for SM and GP respectively. In all cases the non-inferiority of SM compared to SM was shown by ruling out a predefined non-inferiority margin of 5%. CONCLUSIONS: Our study showed the non-inferiority of SM as compared to GP. Moreover, the ex-vivo and intraoperative detection rates at the node level were slightly higher with SM.
Authors: Aidan Cousins; Chris Tsopelas; George Balalis; Sarah K Thompson; Dylan Bartholomeusz; A Bruce Wedding; Benjamin Thierry Journal: J Mater Sci Mater Med Date: 2018-05-29 Impact factor: 3.896
Authors: Andreas Karakatsanis; Peer Michael Christiansen; Lone Fischer; Christina Hedin; Lida Pistioli; Malin Sund; Nils Ryegaard Rasmussen; Hjørdis Jørnsgård; Daniel Tegnelius; Staffan Eriksson; Kosmas Daskalakis; Fredrik Wärnberg; Christos J Markopoulos; Leif Bergkvist Journal: Breast Cancer Res Treat Date: 2016-04-27 Impact factor: 4.872