NSF/FDA SIR: Quantitative Characterization of Hyperspectral Reflectance Imaging Performance for Tissue Diagnostics

高光谱反射成像（HRI）是一项新兴技术，具有广泛的临床应用前景，包括癌症检测和组织血氧测定。然而，目前缺乏标准化的方法来保证HRI成像仪器的质量和一致性。缺乏一套经过良好验证的标准方法来对HRI进行客观、定量评估，这限制了学术界和工业界的创新，并增加了制造商开发临床前测试方法和进行临床研究以证明新产品有效性的负担，从而阻碍了监管过程。这项拟议的研究将产生新颖的、经过验证的图像质量测试方法和幽灵制造技术，以及提高对光谱成像系统的理解，例如那些已提交给FDA的系统。因此，该项目将加强FDA？快速评估基于人力资源调查的创新技术的能力，这些技术在改善公共卫生方面具有巨大潜力。

ABSTRACT #1238407Chen, YuHyperspectral reflectance imaging (HRI) represents an emerging technology with a wide range of current and potential clinical applications including cancer detection and tissue oximetry. However, there is currently a lack of standardized methods to assure the quality and consistency of HRI imaging instruments. The lack of a standard battery of well-validated methods for objective, quantitative evaluation of HRI limits innovation in academia and industry and hampers the regulatory process by increasing the burden on manufacturers to develop preclinical test methods and perform clinical studies to demonstrate the effectiveness of new products. This proposed study will result in novel, validated image quality test methods and phantom fabrication techniques as well as improved understanding of spectral imaging systems such as those that have been submitted to FDA. Thus, this project will enhance FDA?s ability to rapidly evaluate innovative technologies based on HRI that have a strong potential to improve public health.