SIGNIFICANCE Expanded use of fluorescence-guided surgery with devices approved for use with indocyanine green (ICG) has led to a range of commercial systems available. There is a compelling need to be able to independently characterize system performance and allow for cross-system comparisons. AIM The goal of this work is to expand on previous proposed fluorescence imaging standard designs to develop a long-term stable phantom that spectrally matches ICG characteristics and utilizes 3D printing technology for incorporating tissue-equivalent materials. APPROACH A batch of test targets was created to assess ICG concentration sensitivity in the 0.3- to 1000-nM range, tissue-equivalent depth sensitivity down to 6 mm, and spatial resolution with a USAF test chart. Comparisons were completed with a range of systems that have significantly different imaging capabilities and applications, including the Li-Cor® Odyssey, Li-Cor® Pearl, PerkinElmer® Solaris, and Stryker® Spy Elite. RESULTS Imaging of the ICG-matching phantoms with all four commercially available systems showed the ability to benchmark system performance and allow for cross-system comparisons. The fluorescence tests were able to assess differences in the detectable concentrations of ICG with sensitivity differences >10× for preclinical and clinical systems. Furthermore, the tests successfully assessed system differences in the depth-signal decay rate, as well as resolution performance and image artifacts. The manufacturing variations, photostability, and mechanical design of the tests showed promise in providing long-term stable standards for fluorescence imaging. CONCLUSIONS The presented ICG-matching phantom provides a major step toward standardizing performance characterization and cross-system comparisons for devices approved for use with ICG. The developed hybrid manufacturing platform can incorporate long-term stable fluorescing agents with 3D printed tissue-equivalent material. Further, long-term testing of the phantom and refinements to the manufacturing process are necessary for future implementation as a widely adopted fluorescence imaging standard.

中文翻译：

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用于荧光引导手术成像系统表征和性能评估的吲哚菁绿匹配体模。

意义 荧光引导手术的广泛使用以及批准用于吲哚菁绿 (ICG) 的设备已导致一系列商业系统的出现。迫切需要能够独立表征系统性能并允许跨系统比较。目的这项工作的目标是扩展先前提出的荧光成像标准设计，以开发一种长期稳定的体模，该体模在光谱上与 ICG 特性相匹配，并利用 3D 打印技术结合组织等效材料。方法创建了一批测试目标，以评估 0.3 至 1000 nM 范围内的 ICG 浓度灵敏度、低至 6 毫米的组织等效深度灵敏度以及使用美国空军测试图的空间分辨率。对比了一系列具有显着不同成像能力和应用的系统，包括 Li-Cor® Odyssey、Li-Cor® Pearl、PerkinElmer® Solaris 和 Stryker® Spy Elite。结果 ICG 匹配体模与所有四个商用系统的成像显示了对系统性能进行基准测试并允许跨系统比较的能力。对于临床前和临床系统，荧光测试能够评估 ICG 可检测浓度的差异，灵敏度差异 >10 倍。此外，测试成功地评估了系统在深度信号衰减率、分辨率性能和图像伪影方面的差异。制造变化、光稳定性、测试的机械设计表明有望为荧光成像提供长期稳定的标准。结论 所提出的 ICG 匹配体模为标准化性能表征和跨系统比较提供了一个重要的步骤，用于批准与 ICG 一起使用的设备。开发的混合制造平台可以将长期稳定的荧光剂与 3D 打印的组织等效材料相结合。此外，作为广泛采用的荧光成像标准，未来需要对体模进行长期测试并改进制造过程。开发的混合制造平台可以将长期稳定的荧光剂与 3D 打印的组织等效材料相结合。此外，作为广泛采用的荧光成像标准，未来需要对体模进行长期测试并改进制造过程。开发的混合制造平台可以将长期稳定的荧光剂与 3D 打印的组织等效材料相结合。此外，作为广泛采用的荧光成像标准，未来需要对体模进行长期测试并改进制造过程。