Evaluating phototoxicity in contrast-enhanced fluorescence imaging products

评估对比增强荧光成像产品的光毒性

• 批准号: 1836740
• 负责人: Huang Chiao Huang
• 金额: $ 9.4万
• 依托单位: University of Maryland, College Park
• 依托单位国家: 美国
• 项目类别: Standard Grant
• 财政年份: 2019
• 资助国家: 美国
• 起止时间: 2019-01-01 至 2020-12-31
• 项目状态: 已结题
• 来源: https://www.nsf.gov/awardsearch/showAward?AWD_ID=1836740&HistoricalAwards=false
• 关键词: Evaluating; phototoxicity; contrast; enhanced; fluorescence

There is little knowledge established regarding the phototoxicity of fluorescent molecular imaging agents at doses and exposure levels used for imaging, as well as best practices for safety testing of products incorporating these agents. This project fills a major gap by quantitatively characterizing the reactive oxygen species (ROS) generation and cytotoxic potential of common agents. The findings will provide critical regulatory science data needed for a comprehensive approach to safety evaluation. The PI will identify photoproduct and cytotoxicity assays that are robust, validated and suitable for use. This research will generate journal articles to elucidate these photochemical safety issues and guide future medical product developers. This work will ensure consistency in regulatory reviews; address additional issues such as spectral dependency and the impact of tissue scattering in determining safety thresholds, while also helping to evaluate the need for future research on genotoxicity testing of fluorescence imaging products. . This work will provide a strong foundation for establishment of standardized best practices for evaluating the phototoxicity of emerging fluorescence agents. The proposed research will be seamlessly integrated with educational, mentoring, and outreach activities to advance the cross-disciplinary program in the field of Biophotonics and regulatory science. The research results will be disseminated broadly through journal publications, conferences, and workshops held jointly at FDA and UMD. This work will be presented at international conferences on biomedical optics, molecular imaging, and photobiology. The findings will be presented to regulatory reviewers in CDRH to make informed regulatory decisions.This award reflects NSF's statutory mission and has been deemed worthy of support through evaluation using the Foundation's intellectual merit and broader impacts review criteria.

关于荧光分子成像剂在用于成像的剂量和暴露水平下的光毒性以及包含这些试剂的产品的安全性测试的最佳实践，几乎没有建立知识。该项目通过定量表征活性氧（ROS）的产生和常见药物的细胞毒性潜力填补了一个主要空白。这些发现将为全面的安全性评价方法提供所需的关键监管科学数据。PI将确定稳健、经验证且适用的光产物和细胞毒性试验。这项研究将产生期刊文章，以阐明这些光化学安全问题，并指导未来的医疗产品开发。 这项工作将确保监管审查的一致性;解决其他问题，如光谱依赖性和组织散射对确定安全阈值的影响，同时还有助于评估未来对荧光成像产品遗传毒性测试研究的需求。.这项工作将为建立标准化的最佳做法，以评估新兴的荧光剂的光毒性提供了坚实的基础。拟议的研究将与教育，指导和推广活动无缝集成，以推进生物光子学和监管科学领域的跨学科计划。研究结果将通过FDA和UMD联合举办的期刊出版物、会议和研讨会广泛传播。这项工作将在生物医学光学、分子成像和光生物学的国际会议上发表。该奖项反映了NSF的法定使命，并通过使用基金会的知识价值和更广泛的影响审查标准进行评估，被认为值得支持。