Abstract Background Appropriate tracing methods for sentinel lymph node biopsy (SLNB) play a key role in accurate axillary staging. This prospective, non-inferiority, phase III RCT compared the feasibility and diagnostic performance of ultrasound-assisted carbon nanoparticle suspension (CNS) mapping with dual tracer-guided SLNB in patients with early breast cancer. Methods Eligible patients had primary breast cancer without nodal involvement (cN0), or had clinically positive lymph nodes (cN1) that were downstaged to cN0 after neoadjuvant chemotherapy. Patients were randomly assigned (1 : 1) to undergo either ultrasound-assisted CNS sentinel lymph node (SLN) mapping (UC group) or dual tracer-guided mapping with CNS plus indocyanine green (ICG) (GC group). The primary endpoint was the SLN identification rate. Results Between 1 December 2019 and 30 April 2021, 330 patients were assigned randomly to the UC (163 patients) or GC (167 patients) group. The SLN identification rate was 94.5 (95 per cent c.i. 90.9 to 98.0) per cent in the UC group and 95.8 (92.7 to 98.9) per cent in the GC group. The observed difference of –1.3 (–5.9 to 3.3) per cent was lower than the prespecified non-inferiority margin of 6 per cent (Pnon–inferiority = 0.024). No significant difference was observed in metastatic node rate (30.5 versus 24.4 per cent; P = 0.222), median number of SLNs harvested (3 (range 1–7) versus 3 (1–8); P = 0.181), or duration of surgery (mean(s.d.) 7.53(2.77) versus 7.63(3.27) min; P = 0.316) between the groups. Among the subgroup of patients who had undergone neoadjuvant treatment, the SLN identification rate was 91.7 (82.2 to 100) per cent in the UC group and 90.7 (81.7 to 99.7) per cent in the GC group. Conclusion The diagnostic performance of ultrasound-assisted CNS mapping was non-inferior to that of dual tracer-guided SLN mapping with CNS plus ICG in patients with early breast cancer. Registration number NCT04951245 (http://www.clinicaltrials.gov).

中文翻译：

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早期乳腺癌患者超声辅助碳纳米颗粒悬浮标测与双示踪剂引导前哨淋巴结活检 (ultraCars)：III 期随机临床试验

摘要 背景前哨淋巴结活检 (SLNB) 的适当追踪方法对于准确的腋窝分期起着关键作用。这项前瞻性、非劣效性 III 期随机对照试验比较了超声辅助碳纳米颗粒悬浮液 (CNS) 标测与双示踪剂引导的 SLNB 在早期乳腺癌患者中的可行性和诊断性能。 方法符合条件的患者患有无淋巴结受累的原发性乳腺癌（cN0），或具有临床阳性淋巴结（cN1），但在新辅助化疗后降期为cN0。患者被随机分配（1:1）接受超声辅助中枢神经系统前哨淋巴结（SLN）标测（UC 组）或中枢神经系统加吲哚菁绿（ICG）双示踪剂引导标测（GC 组）。主要终点是 SLN 识别率。 结果2019年12月1日至2021年4月30日期间，330名患者被随机分配至UC组（163名患者）或GC组（167名患者）。UC 组的 SLN 识别率为 94.5%（95% CI 90.9 至 98.0），GC 组的 SLN 识别率为 95.8%（92.7 至 98.9）%。观察到的 –1.3%（–5.9 至 3.3）的差异低于预先指定的 6% 的非劣效裕度（Pnon-劣效 = 0.024）。在转移淋巴结率（30.5% 与 24.4%；P = 0.222）、收获的 SLN 中位数（3 个（范围 1-7）与 3 个（1-8）；P = 0.181）或持续时间方面没有观察到显着差异。组间手术时间（平均值（标准差）7.53（2.77）与 7.63（3.27）分钟；P = 0.316）。在接受新辅助治疗的患者亚组中，UC组的SLN识别率为91.7%（82.2%～100%），GC组的SLN识别率为90.7%（81.7%～99.7%）。 结论对于早期乳腺癌患者，超声辅助 CNS 标测的诊断性能不逊色于双示踪剂引导的 CNS 加 ICG 的 SLN 标测。 注册号码NCT04951245 (http://www.clinicaltrials.gov)。