Performance assessment and quality control in fluorescence molecular imaging

Fluorescence molecular imaging (FMI) and endoscopy (FME) hold strong potential to guide interventions and enable earlier, more personalized cancer diagnosis. Alongside novel tracer development, numerous clinical trials are ongoing, and recent FDA approvals of ~20 imaging systems and three tracers (5-ALA, hexaminolevulinate, and pafolacianine) mark significant progress. However, FMI and FME face challenges that hinder consistent clinical interpretation, including variability across systems, which limits repeatability, unbiased readouts, and broad adoption. Standardization efforts are emerging in the literature, with several groups proposing initial guidelines. Here, we present current standardization initiatives and our group’s work on developing multi-parametric, composite standards for quality control and performance assessment. We also outline test designs linked to acquisition parameters and analysis methods that ensure objective system quantification. This framework may support clinical translation and foster integration into robotic-assisted interventions, where repeated sterilization cycles risk degrading system performance.