Oral cavity and oropharyngeal cancers are leading pathologies, representing 3% of all new cancer cases in the United States. Adequate intraoperative marginal clearance of these malignancies is essential for long-term survival; however, presently available techniques limit precise instantaneous tumor margin characterization. Herein, we report the clinical validation of a fiber-based fluorescence lifetime imaging device for real-time intraoperative tumor delineation. Results from 72 human patients are reported (autofluorescence trends, ROC-AUC), including diverse cancer histologies, anatomic sites (e.g. tongue, tonsil, etc.), and patient medical histories. Emphasis is placed on results governing the detection of unknown primary tumors from 4 patients, as well as data from 5 patients presenting with residual carcinoma.
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