Henderson Eric R, Halter Ryan, Paulsen Keith D, Pogue Brian W, Elliott Jonathan, LaRochelle Ethan, Ruiz Alberto, Jiang Shudong, Streeter Samuel S, Samkoe Kimberley S, Gibbs Summer
Thayer school of Engineering, Dartmouth College, Hanover, NH.
Geisel School of Medicine at Dartmouth, Dartmouth College, Hanover, NH.
Proc SPIE Int Soc Opt Eng. 2024 Jan-Feb;12825. doi: 10.1117/12.3010121. Epub 2024 Mar 12.
Guided surgery has demonstrated significant improvements in patient outcomes in some disease processes. Interest in this field has led to substantial growth in the technologies under investigation. Most likely no single technology will prove to be "best," and combinations of macro- and microscale guidance-using radiological imaging navigation, probes (activatable, perfusion, and molecular-targeted; large- and small-molecule), autofluorescence, tissue intrinsic optical properties, bioimpedance, and other characteristics-will offer patients and surgeons the greatest opportunity for high-success/low-morbidity medical interventions. Problems are arising, however, from the lack of valid testing formats; surgical training simulators suffer the same problems. Small animal models do not accurately recreate human anatomy, especially in terms of tissue volume. Large animal models are expensive and have difficulty replicating many pathological states, particularly when molecular specificity for individual cancers is required. Furthermore, the sheer number of technologies and the potential for synergistic combination leads to exponential growth of testing requirements that is unrealistic for in vivo testing. Therefore, critical need exists to expand the ex vivo/in vitro testing platforms available to investigators and, once validated, a need to increase the acceptance of these methods for funding and regulatory endpoints. Herein is a review of the available ex vivo/in vitro testing formats for guided surgery, a review of their advantages/disadvantages, and consideration for how our field may safely and more swiftly move forward through stronger adoption of these testing and validation methods.
在某些疾病进程中，引导手术已证明能显著改善患者预后。对该领域的关注促使正在研究的技术大幅增长。很可能没有单一技术会被证明是“最佳的”，而宏观和微观引导的结合——利用放射成像导航、探头（可激活、灌注和分子靶向；大分子和小分子）、自体荧光、组织固有光学特性、生物阻抗及其他特性——将为患者和外科医生提供实现高成功率/低发病率医疗干预的最大机会。然而，由于缺乏有效的测试形式，问题也随之出现；手术训练模拟器也存在同样的问题。小动物模型无法准确重现人体解剖结构，尤其是在组织体积方面。大型动物模型成本高昂，且难以复制许多病理状态，特别是在需要针对个体癌症的分子特异性时。此外，技术的数量众多以及协同组合的可能性导致测试需求呈指数级增长，这对于体内测试来说是不现实的。因此，迫切需要扩展研究人员可用的离体/体外测试平台，并且一旦经过验证，需要提高这些方法在资金和监管终点方面的接受度。本文对引导手术可用的离体/体外测试形式进行了综述，分析了它们的优缺点，并思考了我们这个领域如何通过更有力地采用这些测试和验证方法来安全、更快地向前发展。
