Abstract
IMPORTANCE: Early-stage oropharyngeal squamous cell carcinoma (OPSCC) is challenging to diagnose using clinical examination and cross-sectional imaging. Ultrasonography performed transorally can provide high-resolution images of oropharyngeal structures; however, whether it improves diagnostic evaluation of patients with suspected OPSCC is unknown, and yet there is a need for improved early detection and T staging. OBJECTIVES: To compare the accuracy of clinical examination, ultrasonography, and magnetic resonance imaging (MRI) in detection of oropharyngeal tumors. DESIGN, SETTING, AND PARTICIPANTS: This multicenter diagnostic clinical trial was conducted in the outpatient clinics of 3 tertiary cancer centers. Consecutive patients with suspected OPSCCs or neck metastases (without visible primary tumors) were screened from February 1, 2023, to June 30, 2024, and those eligible after a clinical examination by a head and neck surgeon were included. Exclusion criteria were a prior head and neck cancer diagnosis or a known histopathologically or imaging-verified oropharyngeal tumor present. Data were analyzed from August 1 to October 31, 2024. INTERVENTION: Surgeon-performed transoral and transcervical ultrasonography of the oropharynx during initial clinical examination followed by cross-sectional imaging (MRI) that was evaluated blinded to results of ultrasonography and histopathologic testing. MAIN OUTCOME AND MEASURE: Oropharyngeal tumor detection with reference to final histopathologic results (presence or absence of an oropharyngeal tumor). RESULTS: The study included 162 participants (median [range] age, 63 [32-85] years; 58 female [35%] and 105 male [65%]), of whom 106 (65%) had an oropharyngeal tumor (OPSCC, 95 [59%]; lymphoma, 7 [4%]; other type, 4 [5%]). Ultrasonography had significantly higher overall accuracy (139 patients [86%]) in correctly diagnosing patients compared to clinical examination (110 [68%]; odds ratio [OR], 0.31; 95% CI, 0.18-0.52) and MRI (123 [76%]; OR, 0.48; 95% CI, 0.28-0.82). The sensitivity of the 3 diagnostic methods to detect oropharyngeal tumors was similar (ultrasonography, 95 patients [90%]; clinical examination, 87 [82%]; MRI, 97 [92%]); however, ultrasonography demonstrated nearly twice the level of specificity in the 56 patients without tumors (44 patients [79%] vs 23 [41%] and 26 [46%], respectively). CONCLUSIONS AND RELEVANCE: This diagnostic clinical trial found that surgeon-performed transoral and transcervical ultrasonography in patients with suspected OPSCC provided higher diagnostic accuracy than clinical examination alone or MRI. Ultrasonography improves the clinical evaluation of suspected oropharyngeal cancers by providing higher diagnostic certainty.