Evaluating phototoxicity in contrast-enhanced fluorescence imaging products

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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.