Implementation of a prospective, multi-center clinical study of dynamic contrast fluorescence imaging to diagnose necrotizing soft-tissue infection: challenges and lessons learned

Necrotizing soft-tissue infections (NSTIs) are rapidly progressive and highly lethal, with diagnostic uncertainty contributing to treatment delays and mortality rates approaching 30%. To address this challenge, a multi-center clinical trial has been initiated to evaluate dynamic contrast-enhanced fluorescence imaging (DCE-FI) with indocyanine green as a rapid diagnostic tool. This technology enables visualization of microvascular thrombi characteristic of NSTIs, distinguishing them from less severe infections. The trial engages seven tertiary centers within a collaborative NSTI study group. This presentation will focus on the execution and implementation of this complex, multi-institutional study, including processes for protocol harmonization, regulatory coordination, and standardized imaging workflows. A key element of implementation was the development of real-time, smartphone-accessible didactic materials to ensure consistent imaging technique, data acquisition, and troubleshooting across all participating sites. Emphasis will be placed on the strategies used to maintain study fidelity and ensure successful completion across centers, enabling validation of DCE-FI as a transformative diagnostic adjunct in NSTI care.