Overall, the history of clinical fluorescence imaging reflects a continual progression from basic research to sophisticated applications in clinical practice, contributing to improved diagnostics and treatment outcomes. Additionally, clinical phase 0 microdosing molecular imaging studies of fluorescent and/or nuclear labelled therapeutic compounds is providing an unprecedented early clinical evaluation tool of novel therapeutic compounds in terms of biodistribution, pharmacokinetics and in vivo and ex vivo mesoscopic tissue distribution in the target population of interest (e.g. oncology, inflammatory diseases[e.g. inflammatory bowel disease, rheumatoid arthritis], cardiovascular and infectious diseases). This provides important qualitative and quantitative data to better prepare phase I (i.e. PK/BD and dose-modelling) and II clinical studies (i.e. on- and off-target data) for de-risking and a more efficient drug development pathway. An overview of the described applications will be given and the envisioned perspectives for the next 10 years of clinical application of fluorescence / optical imaging in clinical applications.
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