Drug-based optical agents: infiltrating clinics at lower risk

Area of Science:

• Biomedical imaging
• Optical diagnostics
• Theranostics

Background:

• Fluorescent agents offer potential for enhanced diagnostics and theranostics.
• Clinical translation of novel fluorescent agents is hindered by regulatory approval challenges.
• Targeted fluorescent agents are currently limited to preclinical applications.

Purpose of the Study:

• To propose a strategy for accelerating the clinical adoption of optical and optoacoustic imaging agents.
• To leverage optically labeled drugs as a method to overcome regulatory bottlenecks.
• To draw parallels with successful strategies in nuclear medicine for clinical translation.

Main Methods:

• Discussing the potential of using optically labeled drugs for clinical imaging.
• Corroborating the proposed strategy with insights from microdosing studies.
• Drawing analogies to established practices in nuclear medicine for regulatory pathways.

Main Results:

• The strategy of using optically labeled drugs shows promise for advancing photonic clinical imaging.
• This approach can potentially overcome existing bottlenecks in the clinical translation of fluorescent agents.
• Microdosing studies support the feasibility and safety of this accelerated pathway.

Conclusions:

• Optically labeled drugs represent a viable approach to accelerate the clinical acceptance of optical and optoacoustic agents.
• This strategy offers a pathway to overcome regulatory hurdles and expand the use of fluorescent agents in clinical settings.
• The integration of this method could significantly advance the field of photonic clinical imaging and theranostics.