Implementation of a Prospective, Multi-Center Clinical Study of Dynamic Contrast Fluorescence Imaging to Diagnose...

Area of Science:

• Medical imaging
• Infectious diseases
• Surgical pathology

Background:

• Necrotizing soft-tissue infections (NSTIs) are life-threatening infections with high mortality rates.
• Diagnostic delays in NSTIs significantly increase patient mortality.
• Current diagnostic methods for NSTIs can be uncertain, leading to delayed treatment.

Purpose of the Study:

• To evaluate dynamic contrast-enhanced fluorescence imaging (DCE-FI) using indocyanine green as a rapid diagnostic tool for NSTIs.
• To assess the feasibility and implementation of a multi-center clinical trial for DCE-FI in NSTI diagnosis.
• To validate DCE-FI as a transformative diagnostic adjunct for NSTI care.

Main Methods:

• A multi-center clinical trial involving seven tertiary centers was initiated.
• Protocol harmonization, regulatory coordination, and standardized imaging workflows were established.
• Real-time, smartphone-accessible didactic materials were developed to ensure consistent imaging technique and data acquisition.

Main Results:

• The study focused on the execution and implementation of a complex, multi-institutional trial.
• Strategies were employed to maintain study fidelity and ensure successful completion across centers.
• DCE-FI demonstrated the ability to visualize microvascular thrombi characteristic of NSTIs.

Conclusions:

• DCE-FI shows potential as a rapid and accurate diagnostic tool for NSTIs.
• Standardized implementation strategies and accessible training materials are crucial for multi-center imaging studies.
• Successful validation of DCE-FI could significantly improve NSTI diagnosis and patient outcomes.