Abstract：
Sentinel lymph node (SLN) detection with superparamagnetic iron oxide (SPIO) nanoparticles has been widely studied and standardized for breast and prostate cancer, but there is scarce evidence concerning its use in vulvar cancer. The objective of this study was to compare SLN detection using a SPIO tracer injected at the time of the surgery detected by a magnetometer, with the standard procedure of using a technetium 99 radioisotope (Tc99) detected by a gamma probe, in patients with vulvar cancer.
The SPIO vulvar cancer study was a single-center prospective interventional non-inferiority study of SPIO compared to Tc99, conducted between 2016 and 2021 in patients who met the GROINSS-V study inclusion criteria for selective sentinel lymph node dissection in vulvar cancer.
We included 18 patients and a total of 41 SLNs. The level of agreement between tracers was 92.7% (80.6%-97.4%), corresponding to 38 out of 41 SLNs, which confirms the non-inferiority of SPIO compared to Tc99. The SLN detection rate per groin was 96.3 (81.7%-99.3) using Tc99 and 100% (87.5%-100%) using SPIO. Both tracers had a detection rate of 100% for positive lymph nodes.
The use of SPIO as a tracer for detecting SLNs in patients with vulvar cancer has shown to be non-inferior to that of the standard radiotracer, with the advantages of not requiring nuclear medicine and being able to inject it at the time of surgery after induction of anesthesia.
The SPIO vulvar cancer study was a single-center prospective interventional non-inferiority study of SPIO compared to Tc99, conducted between 2016 and 2021 in patients who met the GROINSS-V study inclusion criteria for selective sentinel lymph node dissection in vulvar cancer.
We included 18 patients and a total of 41 SLNs. The level of agreement between tracers was 92.7% (80.6%-97.4%), corresponding to 38 out of 41 SLNs, which confirms the non-inferiority of SPIO compared to Tc99. The SLN detection rate per groin was 96.3 (81.7%-99.3) using Tc99 and 100% (87.5%-100%) using SPIO. Both tracers had a detection rate of 100% for positive lymph nodes.
The use of SPIO as a tracer for detecting SLNs in patients with vulvar cancer has shown to be non-inferior to that of the standard radiotracer, with the advantages of not requiring nuclear medicine and being able to inject it at the time of surgery after induction of anesthesia.
摘要：
目的：使用超顺磁性氧化铁（SPIO）纳米颗粒进行前哨淋巴结（SLN）检测已被广泛研究并标准化用于乳腺癌和前列腺癌，但很少有证据表明它在外阴癌中的应用。这项研究的目的是比较SLN检测使用SPIO示踪剂在手术时通过磁力计检测到，使用伽玛探针检测的tech99放射性同位素（Tc99）的标准程序，外阴癌患者。
方法：SPIO外阴癌研究是一项SPIO与Tc99相比的单中心前瞻性介入非劣效性研究，于2016年至2021年在符合GROINSS-V研究纳入标准的患者中进行，用于外阴癌的选择性前哨淋巴结清扫。
结果：我们纳入了18例患者，共41例SLN。示踪剂之间的一致性水平为92.7％（80.6％-97.4％），对应于41个SLN中的38个，这证实了SPIO与Tc99相比的非劣效性。每个腹股沟的SLN检出率为96.3（81.7％-99.3）使用Tc99和100％（87.5％-100％）使用SPIO。两种示踪剂对阳性淋巴结的检出率均为100％。
结论：使用SPIO作为示踪剂来检测外阴癌患者的SLN已显示出非劣于标准放射性示踪剂，具有不需要核医学并且能够在麻醉诱导后在手术时注射它的优点。
方法：SPIO外阴癌研究是一项SPIO与Tc99相比的单中心前瞻性介入非劣效性研究，于2016年至2021年在符合GROINSS-V研究纳入标准的患者中进行，用于外阴癌的选择性前哨淋巴结清扫。
结果：我们纳入了18例患者，共41例SLN。示踪剂之间的一致性水平为92.7％（80.6％-97.4％），对应于41个SLN中的38个，这证实了SPIO与Tc99相比的非劣效性。每个腹股沟的SLN检出率为96.3（81.7％-99.3）使用Tc99和100％（87.5％-100％）使用SPIO。两种示踪剂对阳性淋巴结的检出率均为100％。
结论：使用SPIO作为示踪剂来检测外阴癌患者的SLN已显示出非劣于标准放射性示踪剂，具有不需要核医学并且能够在麻醉诱导后在手术时注射它的优点。
