Comparison of Clinical Feasibility of Magnetic Sentinel Lymph Node Biopsy with Resovist and the Radioisotope Method for Breast Cancer.

[BACKGROUND] Sentinel lymph node biopsy (SLNB) is the standard procedure for axillary staging in early breast cancer. Although the radioisotope (RI) method is highly accurate, it requires nuclear medicine facilities and exposes patients to radiation. Superparamagnetic iron oxide (SPIO) tracers were shown to be noninferior to RI in trials outside Japan but are not approved in Japan. Resovist (ferucarbotran), an MRI contrast agent containing SPIO, may be an alternative. This study compared the feasibility and diagnostic performance of Resovist-based magnetic SLNB with the RI method.

[METHODS] This paired study analyzed 27 breast cancer cases treated with both RI-based and Resovist-based magnetic SLNB. Resovist 0.8 mL was injected subcutaneously above the tumor or into the periareolar region, and the site was gently massaged. The injection-site skin and subcutaneous tissue were excised to prevent pigmentation. Identification rates were assessed at the patient and node levels, and subgroup analysis of patients stratified by body mass index (BMI <25 vs. ≥25) was performed. McNemar's and Fisher's exact tests were used.

[RESULTS] SLN identification was 100% (27/27 patients) for RI and 88.9% (24/27) for the magnetic method. Among 49 nodes, the results were RI+/Mag+ for 34, RI+/Mag- for 6, and RI-/Mag+ for 9, yielding detection rates of 81.6% (RI) and 87.8% (magnetic). No allergic reactions, pigmentation, or injection site complications occurred. BMI had no significant effect (p > 0.05).

[CONCLUSIONS] Resovist-based magnetic SLNB was feasible and safe, and had detection rates comparable to those of RI. Optimization of injection conditions may further improve accuracy.