Background
Oral and oropharyngeal squamous cell carcinoma (OSCC, OPSCC) represent a significant global health burden, with surgical resection being a primary treatment modality. The challenge of achieving tumor-free margins underscores the need for precise intraoperative identification of cancerous tissue.
Methods
A prospective, open-label, single-center, exploratory phase II clinical trial was conducted to evaluate the efficacy of FG001, a novel uPAR-targeting near-infrared imaging agent, in the intraoperative detection of OSCC and OPSCC. The study involved 16 patients who were administered FG001 prior to surgery, with tumor detection quantified through sensitivity and tumor-to-background ratio (TBR).
Results
The trial successfully identified all 16 tumors intraoperatively with a sensitivity of 100% and a mean TBR of 2.99. Histological analysis confirmed tumor-specificity, and no drug-related adverse events were observed. The pharmacokinetic profile of FG001 showed a half-life of 12 hours, with maximal plasma concentrations reached after 1 hour post-injection.
Conclusions
FG001 has demonstrated significant potential for optical molecular imaging in OSCC and OPSCC, offering a promising tool for intraoperative margin delineation and decision-making in surgical cancer management. Further trials are recommended to explore its clinical applications fully.
Keywords
head and neck cancer, fluorescence-guided surgery, optical imaging, uPAR, near-infrared
