Exploratory Study of Superparamagnetic Iron Oxide Dose Optimization in Breast Cancer Sentinel Lymph Node Identification Using a Handheld Magnetic Probe and Iron Quantitation

SIMPLE SUMMARY: Sentinel lymph node biopsy (SLNB) using super magnetic iron oxide (SPIO) and magnetic probes is expected to be a simple and safe method of detecting cancerous lymph nodes without using radioisotopes (RIs). A multicenter trial of SLNB was conducted using a handheld magnetic probe and SPIO (Rizobist(®)) and its non-inferiority with the conventional RI method. The quantity of iron in SLN was measured to examine the necessary dosage and administration method for sufficient SLN detection in the case of this test. Further, a clinical trial was conducted to determine the possibility of SLNB with a half-dose of SPIO (1.0 mL → 0.5 mL), and the resulting iron volume measured at that time was also examined. This study demonstrates that sufficient iron content reaches SLN even at an SPIO dose of 0.5 mL. ABSTRACT: This exploratory study compared doses of ferucarbotran, a superparamagnetic iron oxide nanoparticle, in sentinel lymph nodes (SLNs) and quantified the SLN iron load by dose and localization. Eighteen females aged ≥20 years scheduled for an SLN biopsy with node-negative breast cancer were divided into two equal groups and administered either 1 mL or 0.5 mL ferucarbotran. Iron content was evaluated with a handheld magnetometer and quantification device. The average iron content was 42.8 µg (range, 1.3–95.0; 0.15% of the injected dose) and 21.9 µg (1.1–71.0; 0.16%) in the 1-mL and 0.5-mL groups, respectively (p = 0.131). The iron content of the closest SLN compared to the second SLN was 53.0 vs. 10.0 µg (19% of the injected dose) and 34.8 vs. 4.1 µg (11.1%) for the 1-mL and 0.5-mL groups, respectively (p = 0.001 for both). The magnetic field was high in both groups (average 7.30 µT and 6.00 µT in the 1-mL and 0.5-mL groups, respectively) but was not statistically significant (p = 0.918). The magnetic field and iron content were correlated (overall SLNs, p = 0.02; 1-mL, p = 0.014; 0.5-mL, p = 0.010). A 0.5-mL dose was sufficient for SLN identification. Primary and secondary SLNs could be differentiated based on iron content. Handheld magnetometers could be used to assess the SLN iron content.