Near-infrared fluorescence imaging with an MET-targeting probe for biopsy site selection in patients with oral potentially malignant disorders.

Accurate detection of malignant transformation in oral potentially malignant disorders (OPMDs) is crucial for guiding effective treatment and improving patient management. This study evaluates the potential of MET-binding peptide-indocyanine green (cMBP-ICG), a mesenchymal-epithelial transition factor (MET)-targeted near-infrared fluorescence imaging (NIRFI) probe, for biopsy site selection in OPMDs. Preclinical results demonstrate the superior accuracy of NIRFI-assisted biopsy over conventional oral examination (COE)-based biopsy in detecting high-grade dysplasia (HGD) or squamous cell carcinoma (SCC) and reducing missed detection rates. In a clinical trial with 50 patients, NIRFI-assisted biopsy achieves significantly higher diagnostic accuracy compared to COE-based biopsy (91% vs. 72%, p = 0.0005). These findings underscore the importance of NIRFI in enhancing diagnostic precision, supporting early detection and enabling timely and accurate treatment interventions for patients with OPMDs. The clinical trial is registered under the registration number ChiCTR2300074454.