Standardizing clinical trials in near-infrared fluorescence imaging: a workflow and regulatory framework proposal

Near-infrared fluorescence imaging (NIR) is an emerging imaging modality that enhances the real-time, precise visualization of (pre)cancerous tissue during surgical and endoscopic procedures. Despite its growing adoption, the lack of standardized protocols in clinical trials hinders the comparability of results and broader clinical adaptation. This manuscript identifies key factors influencing fluorescence signal variability, categorizing them into non-adaptable and adaptable. We propose a comprehensive workflow and guidelines to standardize clinical trial protocols, ensuring reproducibility and facilitating regulatory approval. As a Perspective, we outline a standardization framework—rather than new clinical datasets—to advance NIR imaging toward routine clinical use and improved patient outcomes.