论文标题：Implementation and benchmarking of a novel analytical framework to clinically evaluate tumor-specific fluorescent tracers
期刊：
作者：Marjory Koller, Si-Qi Qiu, Matthijs D. Linssen, Liesbeth Jansen, Wendy Kelder, Jakob de Vries, Inge Kruithof, Guo-Jun Zhang, Dominic J. Robinson, Wouter B. Nagengast, Annelies Jorritsma-Smit, Bert van der Vegt & Gooitzen M. van Dam
发表时间：2018/09/18
数字识别码：10.1038/s41467-018-05727-y
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《自然-通讯》发表的一项小型临床试验研究Implementation and benchmarking of a novel analytical framework to clinically evaluate tumor-specific fluorescent tracers报道了一种评估荧光示踪剂用于确定乳腺癌手术期间肿瘤边缘的方法。试验结果表明，荧光示踪剂bavacizumab-800CW是安全的，它可以显著改进乳腺癌患者肿瘤边缘的检测。
图1：临床分析框架使术中荧光信号与组织病理学相关。图源：Koller等
在肿瘤切除期间，外科医生依靠视觉检查和触诊（在检查身体时用手指或手感觉的方法）来检测肿瘤边缘，但是这种方法不精确。荧光示踪剂允许靶向肿瘤细胞并且正在临床试验中进行测试，但是缺乏用于确定荧光示踪剂功效的标准化方法。另外，当前的方法不容易进行术中监测，并且需要耗时的组织切片处理，或者用到诸如计算机断层扫描和磁共振成像之类的技术，而这些技术在手术期间不能实时使用。
荷兰格罗宁根大学明升手机版中心的Marjory Koller、Gooitzen van Dam及其同事报道了一项临床剂量递增试验的结果，该试验旨在评估荧光示踪剂bavacizumab-800CW在26例乳腺癌手术患者中的应用效果，即把它应用于现有手术流程中实时检测肿瘤边缘。
图2：荧光示踪剂bavacizumab-800CW下的乳腺癌组织的微观生物分布。图源：Koller 等
研究结果表明，荧光成像是安全的，并且使肿瘤边缘术中检出率上升88%。目前还需要开展进一步的研究以确定该技术是否可以减少保乳手术期间肿瘤阳性边缘的数量（其中癌细胞存在于被移除组织的外边缘中），降低术后的二次手术率。
摘要：During the last decade, the emerging field of molecular fluorescence imaging has led to the development of tumor-specific fluorescent tracers and an increase in early-phase clinical trials without having consensus on a standard methodology for evaluating an optical tracer. By combining multiple complementary state-of-the-art clinical optical imaging techniques, we propose a novel analytical framework for the clinical translation and evaluation of tumor-targeted fluorescent tracers for molecular fluorescence imaging which can be used for a range of tumor types and with different optical tracers. Here we report the implementation of this analytical framework and demonstrate the tumor-specific targeting of escalating doses of the near-infrared fluorescent tracer bevacizumab-800CW on a macroscopic and microscopic level. We subsequently demonstrate an 88% increase in the intraoperative detection rate of tumor-involved margins in primary breast cancer patients, indicating the clinical feasibility and support of future studies to evaluate the definitive clinical impact of fluorescence-guided surgery.
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