超低剂量超顺磁性氧化铁纳米颗粒注射用于乳腺癌前哨淋巴结检测：前瞻性队列研究

Ultra-low dose superparamagnetic iron oxide nanoparticle injection for sentinel lymph node detection in breast cancer: prospective cohort study.

作者信息

Sundh Lovisa, Alzoubi Marya, Abu-Oddos Nizar, Båtelsson Sarah, Nyman Per, Karakatsanis Andreas, Eriksson Staffan, Ravichandran Mookaiah, Chin Kian, Olofsson Bagge Roger, Mirzaei Nushin, Wärnberg Fredrik

机构信息

Department of Surgery, Region Västra Götaland, Sahlgrenska University Hospital, Gothenburg, Sweden.

Department of Surgery, Institute of Clinical Sciences, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.

出版信息

Br J Surg. 2025 Jul 3;112(7). doi: 10.1093/bjs/znaf129.

DOI:10.1093/bjs/znaf129

PMID:40698872

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC12284759/

Abstract

BACKGROUND

Sentinel lymph node (SLN) staging is essential in breast cancer. Superparamagnetic iron oxide nanoparticles (SPIO) is a tracer where the optimal injection technique is yet not defined. The aim was to evaluate SLN detection using 0.1 ml SPIO intradermally compared to technetium-99 m (Tc99) ± blue dye.

METHOD

Patients planned for breast surgery and SLN biopsy received 0.1 ml SPIO intradermally at the areolar border or over the tumour. Tc99 ± blue dye was administered per clinical routine. Magnetic, radioactive, or blue nodes were removed and analysed separately. SLN detection and numbers, concordance, and skin discoloration were analysed.

RESULTS

A total of 216 patients were included at five hospitals. Median age was 63 years, tumour size 15.9 mm, and 91.7% underwent breast conservation. SPIO was injected a median of 12 days before surgery. SLN detection was 211/216 (97.7%; 95% c.i.: 94.7 to 99.2) and 215/216 (99.5%; 95% c.i.: 98.6 to 100.0) for SPIO and Tc99 ± blue dye (P = 0.111) respectively. In total, 403 SLNs were removed; 341 detected by SPIO and 349 by Tc99 ± blue dye. The median number of SLNs was 1 (iqr: 1-2) for both tracer methods. Among 46 SLN-positive patients, 42 were correctly staged with both tracers, two with SPIO only and two with Tc99 ± blue dye only. Skin discoloration was evaluated in 107 patients. The median discoloured area was 0 cm2 (iqr: 0-0.7) among 49 patients with the injection site surgically removed and 1.3 cm2 (iqr: 0.6-2.8) among 58 without removal.

CONCLUSION

An ultra-low dose of 0.1 ml intradermal injection of SPIO was non-inferior to Tc99 ± blue dye for SLN detection. Skin discoloration was limited and further reduced by removal during surgery.

摘要

背景

前哨淋巴结（SLN）分期在乳腺癌中至关重要。超顺磁性氧化铁纳米颗粒（SPIO）是一种示踪剂，其最佳注射技术尚未明确。目的是评估与99m锝（Tc99）±蓝色染料相比，皮内注射0.1 ml SPIO对前哨淋巴结的检测情况。

方法

计划进行乳腺手术和前哨淋巴结活检的患者在乳晕边缘或肿瘤上方皮内注射0.1 ml SPIO。按照临床常规给予Tc99±蓝色染料。切除磁性、放射性或蓝色淋巴结并分别进行分析。分析前哨淋巴结的检测情况、数量、一致性以及皮肤变色情况。

结果

五家医院共纳入216例患者。中位年龄为63岁，肿瘤大小为15.9 mm，91.7%的患者接受了保乳手术。SPIO在手术前中位12天注射。SPIO和Tc99±蓝色染料检测到前哨淋巴结的比例分别为211/216（97.7%；95%置信区间：94.7至99.2）和215/216（99.5%；95%置信区间：98.6至100.0）（P = 0.111）。总共切除了403个前哨淋巴结；SPIO检测到341个，Tc99±蓝色染料检测到349个。两种示踪方法检测到的前哨淋巴结中位数量均为1个（四分位间距：1 - 2）。在46例前哨淋巴结阳性患者中，两种示踪剂均正确分期的有42例，仅SPIO正确分期的有2例，仅Tc99±蓝色染料正确分期的有2例。对107例患者的皮肤变色情况进行了评估。49例手术切除注射部位的患者中，变色面积中位数为0 cm²（四分位间距：0 - 0.7），58例未切除的患者中，变色面积中位数为1.3 cm²（四分位间距：0.6 - 2.8）。