Statistical analysis
OSCC, tumors
TUMORS
Historical data in our center showed a tumor-positive margin rate of 15–20%. Consequently, in our study design, we included 70 patients and expected 14 to have a tumor-positive margin. Considering the EGFR overexpression rate of 90% in OSCC, potentially leading to inadequate fluorescence in 10% of the tumors, we expected to detect at least 12 out of 14 tumor-positive margins. Given the sample size, this would result in a sensitivity of 86% (95% CI 60–96%), yielding sufficient precision with regard to the expected impact on real-time intraoperative margin assessment, allowing the informed design of a subsequent comparative randomized study. Estimates of specificity were expected to be even more precise given the predicted larger number of patients with tumor-negative margins. Descriptive statistics were performed on the patient demographics, clinical and pathological data. Data were presented as median + range, mean + standard deviation, frequencies, and percentages. Imaging data are presented as relative values (i.e., SBR). MDSFR/SFF values are reported as intrinsic fluorescence, defined as a product of the quantum efficiency across the emission spectrum, where Q is the fluorescence quantum yield of IRDye-800CW and μ