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

摘要#1238407Chen，YuHyperspectral reflectance imaging（HRI）是一种新兴技术，具有广泛的当前和潜在临床应用，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。缺乏一套经过充分验证的客观、定量评估HRI的标准方法，限制了学术界和工业界的创新，并通过增加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来阻碍监管过程。这项拟议的研究将产生新的、经验证的图像质量测试方法和体模制造技术，并提高对光谱成像系统（如已提交给FDA的系统）的理解。因此，该项目将提高FDA？快速评估基于HRI的创新技术的能力，这些技术具有改善公共卫生的强大潜力。

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.