多模式癌胚抗原靶向荧光和放射性引导的细胞减灭术治疗结直肠源性腹膜转移：单臂验证性试验
Multimodal carcinoembryonic antigen-targeted fluorescence and radio-guided cytoreductive surgery for peritoneal metastases of colorectal origin: single-arm confirmatory trial.
作者信息
Darai Aaya, de Gooyer Jan Marie, Ubels Sander, Bremers Andreas J A, de Reuver Philip R, Aarntzen Erik H J G, Nagtegaal Iris D, Rijpkema Mark, de Wilt Johannes H W
机构信息
Department of Surgery, Radboud University Medical Centre, Nijmegen, the Netherlands.
Department of Medical Imaging and Nuclear Medicine, Radboud University Medical Centre, Nijmegen, the Netherlands.
出版信息
BJS Open. 2025 Mar 4;9(2). doi: 10.1093/bjsopen/zraf045.
BACKGROUND
Selection of suitable candidates for intraoperative tumour detection and cytoreductive surgery (CRS) combined with hyperthermic intraperitoneal chemotherapy (HIPEC) is important for improving outcomes for patients with colorectal peritoneal metastases. Previous research demonstrated the use of single-photon emission computed tomography (SPECT), intraoperative radiodetection, and near-infrared fluorescence (NIRF)-guided surgery with a dual-labelled 111In-labelled dodecane tetra-acetic acid (DOTA)-labetuzumab-IRDye800CW tracer to detect peritoneal metastases before operation. The aim of this study was to validate these results.
METHODS
A single-centre phase II study was conducted to evaluate the safety and feasibility of 111In-labelled DOTA-labetuzumab-IRDye800CW in patients with colorectal peritoneal metastases undergoing CRS-HIPEC. SPECT/computed tomography (CT) was undertaken before surgery, after intravenous administration of 10 mg 111In-labelled DOTA-labetuzumab-IRDye800CW (mean 101.25 MBq). During surgery, radiodetection and NIRF imaging were used for tumour detection. Adverse events were assessed, and tumour-to-background ratios (TBRs) and peritoneal cancer index scores were analysed.
RESULTS
Seven patients were included. No study-related severe adverse events were reported. Imaging before surgery revealed previously undetected metastases in one patient. The mean(standard deviation, s.d.) SPECT/CT peritoneal cancer index score was 3(2), and the intraoperative score was 14(7) (P = 0.032). A total of 52 lesions were removed during CRS, of which 37 were malignant. With NIRF imaging, 34 (92%) of 37 malignant lesions were detectable. Of 52 fluorescent lesions, 4 were false-positive. Mean(s.d.) fluorescence TBR was 3.4(1.8) and mean radiodetection TBR was 4.4(1.4).
CONCLUSION
This study confirmed the safety and feasibility of multimodal image-guided surgery in patients with peritoneal metastases.
背景
选择合适的患者进行术中肿瘤检测以及细胞减灭术（CRS）联合热灌注化疗（HIPEC）对于改善结直肠癌腹膜转移患者的预后至关重要。先前的研究表明，使用单光子发射计算机断层扫描（SPECT）、术中放射探测以及近红外荧光（NIRF）引导手术，采用双标记的111铟标记十二烷四乙酸（DOTA）- 拉贝妥珠单抗 - IRDye800CW示踪剂在术前检测腹膜转移灶。本研究的目的是验证这些结果。
方法
进行了一项单中心II期研究，以评估111铟标记的DOTA - 拉贝妥珠单抗 - IRDye800CW在接受CRS - HIPEC的结直肠癌腹膜转移患者中的安全性和可行性。在静脉注射10 mg 111铟标记的DOTA - 拉贝妥珠单抗 - IRDye800CW（平均101.25 MBq）后，手术前进行SPECT/计算机断层扫描（CT）。手术过程中，使用放射探测和NIRF成像进行肿瘤检测。评估不良事件，并分析肿瘤与背景比值（TBRs）和腹膜癌指数评分。
结果
纳入7例患者。未报告与研究相关的严重不良事件。术前成像显示1例患者有先前未检测到的转移灶。SPECT/CT腹膜癌指数评分的平均值（标准差，s.d.）为3（2），术中评分为14（7）（P = 0.032）。CRS期间共切除52个病灶，其中37个为恶性。通过NIRF成像，37个恶性病灶中的34个（92%）可检测到。在52个荧光病灶中，4个为假阳性。荧光TBR的平均值（s.d.）为3.4（1.8），放射探测TBR的平均值为4.4（1.4）。
结论
本研究证实了多模态图像引导手术在腹膜转移患者中的安全性和可行性。
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