Standardization and implementation of fluorescence molecular endoscopy in the clinic.

Standardization and implementation of fluorescence molecular endoscopy in the clinic.
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临床中荧光分子内窥镜检查的标准化和实施。

DOI:
10.1117/1.jbo.27.7.074704
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发表时间:
2022-03
影响因子:
3.5
通讯作者:
Gorpas D
Gorpas D
中科院分区:
医学3区
文献类型:
--
作者:
Sterkenburg AJ;Hooghiemstra WTR;Schmidt I;Ntziachristos V;Nagengast WB;Gorpas D

文献摘要

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近红外荧光分子内窥镜(NIR-FME)是一种能够在体内可视化中空器官分子过程的创新技术。尽管NIR-FME具有临床翻译的潜力,但它仍然面临挑战,例如,在执行质量控制和程序和系统标准化方面缺乏共识。这可能会阻碍当局对该技术的临床批准和内窥镜医生的接受。到目前为止,已经进行了几项使用NIR-FME的临床试验。然而,这些试验中的大多数都有不同的研究设计,这使得比较变得困难。我们描述了NIR-FME标准化的必要性,提供了建立标准化临床研究的途径,并描述了NIR-FME的未来前景。由于有许多参数,标准化是具有挑战性的。不变参数指的是硬件规格。可变参数指的是运动或组织的光学属性。在定义这些变量的影响或标准化程序时,幻影可能会有所帮助。NIR-FME需要标准化,在实现NIR-FME的广泛临床应用之前,仍然需要克服障碍。当这些障碍被克服时,临床结果可以进行比较,系统可以进行基准测试,从而使临床实施成为可能。
Near-infrared fluorescence molecular endoscopy (NIR-FME) is an innovative technique allowing for in vivo visualization of molecular processes in hollow organs. Despite its potential for clinical translation, NIR-FME still faces challenges, for example, the lack of consensus in performing quality control and standardization of procedures and systems. This may hamper the clinical approval of the technology by authorities and its acceptance by endoscopists. Until now, several clinical trials using NIR-FME have been performed. However, most of these trials had different study designs, making comparison difficult. We describe the need for standardization in NIR-FME, provide a pathway for setting up a standardized clinical study, and describe future perspectives for NIR-FME. Standardization is challenging due to many parameters. Invariable parameters refer to the hardware specifications. Variable parameters refer to movement or tissue optical properties. Phantoms can be of aid when defining the influence of these variables or when standardizing a procedure. There is a need for standardization in NIR-FME and hurdles still need to be overcome before a widespread clinical implementation of NIR-FME can be realized. When these hurdles are overcome, clinical outcomes can be compared and systems can be benchmarked, enabling clinical implementation.