本研究的目的是比较超顺磁性氧化铁（SPIO）引导技术和标准技术在早期乳腺癌的哨兵淋巴结（SLN）检测中的疗效。多项劣性试验已经得出结论，SPIO检测SLN的非劣性不亚于传统的放射性同位素技术，无论是否涉及蓝染料。从2018年7月到2022年8月，临床诊断为无淋巴结侵袭性乳腺癌的患者被随机分入研究组（SPIO）和对照组（放射性同位素和蓝染剂）。患者数据和疾病特征被预先收集。比较两组SLN检测率。总共招募了282名患者进行288次哨兵淋巴结活检（SLNB）程序，每组随机分配了144次SLNB程序。基线患者和疾病特征是可比较的。每组各一个患者SLN定位失败；SLNB成功率为99.3％。SPIO组收获SLN的平均数更高（3.3对2.8，p = 0.039），手术持续时间更长（33.1分钟对22.3分钟，p = 0.01）比对照组表现更好。在研究组中，每个患者和淋巴结的一致性率分别为99.3％和94.6％。在37名患者中检测到了67个阳性SLN。每个恶性SLNB程序和阳性SLN的一致性率分别为97.3％和96.8％。单一示踪剂SPIO引导的SLNB不劣于双重技术（放射性同位素和蓝染剂），可安全替代早期乳腺癌的SLN映射金标准。 ©2023年。外科肿瘤学会。

The objective of this study is to compare the efficacy of the superparamagnetic iron oxide (SPIO)-guided and standard techniques for sentinel lymph node (SLN) detection in early breast cancer. Multiple inferiority trials have concluded the non-inferiority of SPIO to the conventional radioisotope technique, with or without blue dye, in detecting SLNs.From July 2018 to August 2022, patients clinically diagnosed with node-negative invasive breast cancer were randomised into the study group (SPIO) and control group (radioisotope and blue dye). Patient data and disease characteristics were prospectively collected. SLN detection rates were compared between the two groups.A total of 282 patients undergoing 288 sentinel lymph node biopsy (SLNB) procedures were recruited, and 144 SLNB procedures were randomised into each group. The baseline patient and disease characteristics were comparable. SLN localisation failed in one patient in each group; the success rate of SLNB was 99.3%. The SPIO group demonstrated a higher mean number of SLNs harvested (3.3 versus 2.8, p = 0.039) and longer mean procedure duration (33.1 min versus 22.3 min, p = 0.01) than the control group did. In the study group, the concordance rates per patient and node were 99.3% and 94.6%, respectively. Sixty-seven positive SLNs were detected in 37 patients. The concordance rates per malignant SLNB procedure and positive SLN were 97.3% and 96.8%, respectively.Single-tracer SPIO-guided SLNB was non-inferior to the dual technique (radioisotope and blue dye) and could safely replace the gold standard for SLN mapping in early breast cancer.© 2023. Society of Surgical Oncology.