Multicenter clinical trial on sentinel lymph node biopsy using superparamagnetic iron oxide nanoparticles and a novel handheld magnetic probe.
BACKGROUND
Sentinel lymph node biopsy is a standard staging procedure for early axillary lymph node-negative breast cancer. As an alternative to the currently used radioactive tracers for sentinel lymph node (SLN) detection during the surgical procedure, a number of studies have shown promising results using superparamagnetic iron oxide (SPIO) nanoparticles. Here, we developed a new handheld, cordless, and lightweight magnetic probe for SPIO detection.


METHODS
Resovist (SPIO nanoparticles) were detected by the newly developed handheld probe, and the SLN detection rate was compared to that of the standard radioisotope (RI) method using radioactive colloids (99m Tc) and a blue dye (indigo carmine). This was a multicenter prospective clinical trial that included 220 patients with breast cancer scheduled for sentinel node biopsy after a clinical diagnosis of negative axillary lymph node from three facilities in Japan.


RESULTS
Of the 210 patients analyzed, SLN was detected in 94.8% (199/210 cases, 90% confidence interval [CI]) with our magnetic method and in 98.1% (206/210 cases, 90% CI) with the RI method. The magnetic method exceeded the threshold identification rate of 90%.


CONCLUSION
This was the first clinical study to use a novel handheld magnetometer to detect SLN, which we demonstrate to be not inferior to the RI method.
['Taruno|Kanae|K|http://orcid.org/0000-0002-7754-1548', 'Kurita|Tomoko|T|', 'Kuwahata|Akihiko|A|', 'Yanagihara|Keiko|K|', 'Enokido|Katsutoshi|K|', 'Katayose|Yoshihisa|Y|', 'Nakamura|Seigo|S|', 'Takei|Hiroyuki|H|', 'Sekino|Masaki|M|', 'Kusakabe|Moriaki|M|']
D000328:Adult D000368:Aged D000369:Aged, 80 and over D001943:Breast Neoplasms D004396:Coloring Agents D003287:Contrast Media D003911:Dextrans D005260:Female D005290:Ferric Compounds D006801:Humans D007203:Indigo Carmine D058185:Magnetite Nanoparticles D060306:Magnetometry D008875:Middle Aged D011446:Prospective Studies D019275:Radiopharmaceuticals D000071036:Sentinel Lymph Node D021701:Sentinel Lymph Node Biopsy
sentinel lymph node biopsy superparamagnetic iron oxide magnetic probe breast cancer