研究动态
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SGM-101的术中分子影像学在结直肠肺转移的可行性研究。

Intraoperative molecular imaging of colorectal lung metastases with SGM-101: a feasibility study.

发表日期:2023 Aug 08
作者: Ruben P J Meijer, Hidde A Galema, Robin A Faber, Okker D Bijlstra, Alexander P W M Maat, Françoise Cailler, Jerry Braun, Stijn Keereweer, Denise E Hilling, Jacobus Burggraaf, Alexander L Vahrmeijer, Merlijn Hutteman,
来源: Eur J Nucl Med Mol I

摘要:

在结直肠癌肺转移(CLM)患者中,转移切除术是常见的治疗选择。在微创手术中,边缘评估和小结节的识别存在挑战。术中荧光成像能够克服这些挑战。本研究旨在评估使用癌胚抗原(CEA)特异性荧光示踪剂SGM-101定位CLM的可行性。这是一项前瞻性、开放标签的可行性研究。主要结局是显示使用SGM-101的CLM中显示真阳性荧光信号的数量。荧光阳性信号定义为信号与背景比(SBR)≥1.5。副终点是通过免疫组化评估结直肠肺转移中的CEA表达,并由总免疫染色评分进行评分。 本研究纳入了13例患者。分别观察到活体、术后、封闭场犁切成像中的阳性荧光信号分别为31%、45%和94%的肿瘤。三种成像方式的中位SBR分别为1.00(IQR: 1.00-1.53)、1.45(IQR: 1.00-1.89)和4.81(IQR: 2.70-7.41)。所有肿瘤病灶的CEA表达的最大总免疫染色评分为12/12。 本研究证实了使用SGM-101荧光成像定位CLM的潜力。所有肿瘤病灶均观察到CEA表达,并且封闭场成像显示示踪剂对肿瘤结节的CEA特异性定位优秀。通过改进微创成像系统和优化患者选择,SGM-101在体内示踪剂检测的全部潜力可以得到实现。 该研究已在ClinicalTrial.gov注册,注册号为NCT04737213,注册日期为2021年2月。 © 2023. 作者。
Metastasectomy is a common treatment option for patients with colorectal lung metastases (CLM). Challenges exist with margin assessment and identification of small nodules, especially during minimally invasive surgery. Intraoperative fluorescence imaging has the potential to overcome these challenges. The aim of this study was to assess feasibility of targeting CLM with the carcinoembryonic antigen (CEA) specific fluorescent tracer SGM-101.This was a prospective, open-label feasibility study. The primary outcome was the number of CLM that showed a true positive fluorescence signal with SGM-101. Fluorescence positive signal was defined as a signal-to-background ratio (SBR) ≥ 1.5. A secondary endpoint was the CEA expression in the colorectal lung metastases, assessed with the immunohistochemistry, and scored by the total immunostaining score.Thirteen patients were included in this study. Positive fluorescence signal with in vivo, back table, and closed-field bread loaf imaging was observed in 31%, 45%, and 94% of the tumors respectively. Median SBRs for the three imaging modalities were 1.00 (IQR: 1.00-1.53), 1.45 (IQR: 1.00-1.89), and 4.81 (IQR: 2.70-7.41). All tumor lesions had a maximum total immunostaining score for CEA expression of 12/12.This study demonstrated the potential of fluorescence imaging of CLM with SGM-101. CEA expression was observed in all tumors, and closed-field imaging showed excellent CEA specific targeting of the tracer to the tumor nodules. The full potential of SGM-101 for in vivo detection of the tracer can be achieved with improved minimal invasive imaging systems and optimal patient selection.The study was registered in ClinicalTrial.gov under identifier NCT04737213 at February 2021.© 2023. The Author(s).