摘要:This study aimed to evaluate the diagnostic performance of a non-radiating, noninvasive infrared (IR) thermal imaging system in the detection of cervical lymph node metastasis from oral cavity cancer. In this prospective clinical trial, a total of 90 oral cavity cancer patients suspected of having cervical lymph node metastasis underwent IR imaging of the neck prior to neck dissection. Analysis of the IR images was performed by two methods: manual qualitative analysis and automatic analysis by an entropy-gradient support vector machine (EGSVM). The efficacies of the EGSVM-based infrared thermal imaging system and contrast-enhanced computed tomography (CT) were compared by using the Noninferiority Testing. Compared with manual qualitative analysis, the EGSVM-based automatic analysis had a higher sensitivity (84.8% vs. 71.7%), specificity (77.3% vs. 72.7%), accuracy (81.1% vs. 72.2%), positive predictive value (79.6% vs. 73.3%) and negative predictive value (82.9% vs. 71.1%). The EGSVM-based infrared thermal imaging system was noninferior to contrast-enhanced CT (P < 0.05). The EGSVM-based infrared thermal imaging system showed a trend of higher sensitivity, whereas contrast-enhanced CT showed a trend of higher specificity. The EGSVM-based infrared thermal imaging system is a promising non-radiating, noninvasive tool for the detection of lymph node metastasis from oral cavity cancer.