Introduction. Technetium-labeled sulfur colloid (TSC) is a radiolabeled mapping agent commonly used for sentinel lymph node biopsy (SLNBx). Tilmanocept, a CD206 receptor-targeted mapping agent, has gained recent popularity due to potential advantages of rapid and quick uptake to the SLNs. The objectives of this study were to assess (1) the difference in the number of SLNs harvested using tilmanocept versus TSC and (2) the difference in time to transcutaneous localization when using an intraoperative injection approach. Methods. Patients undergoing breast conservation and SLNBx were consented and randomized to receive either 0.5 mCi of filtered TSC or 0.5 mCi of tilmanocept injected intradermally immediately after induction of anesthesia. Axillary transcutaneous gamma detector probe counts were taken at 1-minute intervals until a hot spot was identified. SLNs were then identified and excised. Additional nodes were excised if their counts per second (cps) were greater than 10% of the cps of the hottest SLN. The number of SLNs was based on both number of nodes collected intraoperatively and the number recorded in the final pathology report. Results. The study population consisted of 86 patients, 48 randomized to tilmanocept and 38 to TSC. There were no significant differences in patient or tumor characteristics between the two groups. Localization rates were 100% for both cohorts. The mean number of SLNs identified and removed was not significantly different (, intraoperatively; , pathology reported). Time to transcutaneous localization was 3.3 ± 2.0 minutes for tilmanocept and 3.9 ± 2.3 minutes for TSC (). The average cps for the hottest node was 2,180.0 ± 2,460.5 in the tilmanocept group compared to 2,679.3 ± 2,687.5 in the TSC group (). Conclusion. There was no significant difference in the number of SLNs harvested or in the time to transcutaneous localization when using tilmanocept versus TSC as the radiolabeled mapping agents for intraoperative injection and mapping. Either agent can be used without any significant difference in performance.

中文翻译：

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一项前瞻性双盲随机对照试验，比较术中注射锝 Tc 99m Tilmanocept 与锝 Tc 99m 硫胶体在乳腺癌淋巴映射中的作用

简介。锝标记的硫胶体 (TSC) 是一种放射性标记的标测试剂，通常用于前哨淋巴结活检 (SLNBx)。Tilmanocept 是一种 CD206 受体靶向图谱剂，由于快速和快速吸收 SLN 的潜在优势，最近受到欢迎。本研究的目的是评估 (1) 使用 tilmanocept 与 TSC 收获的 SLN 数量的差异和 (2) 使用术中注射方法时经皮定位的时间差异。方法. 接受乳房保护和 SLNBx 的患者被同意并随机接受 0.5 mCi 的过滤 TSC 或 0.5 mCi 的替马诺西普，在麻醉诱导后立即皮内注射。每隔 1 分钟对腋窝经皮伽马检测器探针计数，直到识别出热点。然后识别并切除 SLN。如果其他节点的每秒计数 (cps) 大于最热 SLN 的 cps 的 10%，则切除其他节点。SLN 的数量基于术中收集的节点数量和最终病理报告中记录的数量。结果. 研究人群由 86 名患者组成，其中 48 名随机分配至 tilmanocept，38 名分配至 TSC。两组患者或肿瘤特征无显着差异。两个队列的本地化率均为 100%。识别和移除的 SLN 的平均数量没有显着差异（,术中;，病理报告）。tilmanocept 经皮定位时间为 3.3 ± 2.0 分钟，TSC 为 3.9 ± 2.3 分钟（）。tilmanocept 组最热节点的平均 cps 为 2,180.0 ± 2,460.5，而 TSC 组为 2,679.3 ± 2,687.5 (）。 结论。当使用 tilmanocept 与 TSC 作为放射性标记的标测剂进行术中注射和标测时，收获的 SLN 数量或经皮定位时间没有显着差异。任何一种代理都可以使用，性能没有任何显着差异。