This study protocol for a prospective, multicenter, diagnostic, clinical trial describes the integration of transoral and transcervical ultrasonography (US) in the initial clinical work-up of patients referred to tertiary head and neck cancer centers with suspected oropharyngeal cancer. The study evaluates the blinded detection rate of oropharyngeal tumors and their US-estimated size and T-stage before histopathology and cross-sectional imaging are available. Magnetic resonance imaging (MRI) scans will be prospectively rated while blinded to T-site histopathology and US. The primary outcome measures of diagnostic accuracy, including sensitivity, specificity, positive and negative predictive values, and overall accuracy, will be reported for both US and MRI. A sub-analysis of prospectively rated 18F-Fluorodeoxyglucose (FDG) positron emission tomography/computerized tomography (PET/CT) scans in patients with clinically suspected unknown primary tumors will also be compared to US and MRI. Secondary outcome measures, including a comparison of tumor size estimation between US, MRI, and CT, will also be reported. This prospective multicenter study will provide clinically impactful information regarding the use of transoral and transcervical US for the diagnostic work-up of oropharyngeal cancer.

Objective : We present the first clinical experience with the BIOGRAPH One next-generation PET/MRI system scanner, evaluating its performance for body and brain imaging in patients across multiple tracers. Methods: A total of 59 patients were scanned on the BIOGRAPH One PET/MRI following standard clinical PET/CT (n = 52) or first-generation PET/MRI (Biograph mMR, n = 7). Scans comprised 30 total body (TB), whole body (WB), or regional scans with [¹⁸F]FDG, and 29 brain scans with either [¹⁸F]FDG (n = 5), [¹⁸F]FE-PE2I (n = 10), [¹⁸F]FET (n = 4), or [⁶⁸Ga]Ga-DOTATOC (n = 10). The PET image quality was visually assessed using a 5-point Likert scale (1 = very good to 5 = very bad) and compared with clinical scans acquired on either a current-generation digital PET/CT or a first-generation PET/MRI system, including evaluation of diagnostic concordance. PET quantification and image noise was compared in brain and WB/TB [¹⁸F]FDG PET scans. Results: PET image quality was rated as good or very good in 93% of scans with a median [inter-quartile range] score of 1.5 [1.5;2]. In 99% of cases, image quality was judged equal to or better than the clinical reference scan (median score 3 [2.5;3]). Diagnostic concordance was observed in 99% of readings. Imaging metrics revealed the anticipated regional bias in brain imaging, while no significant bias was observed in body imaging. Image noise was comparable to that observed with digital PET/CT and demonstrated superiority over first-generation PET/MRI despite potential degradation related to isotope decay in BIOGRAPH One PET/MRI acquisitions scans performed at the end of the imaging workflow. Conclusions: Within the study limitations related to sequential imaging, the BIOGRAPH One PET/MRI scanner demonstrated improved PET sensitivity and workflow potential over its first-generation predecessor, which may allow for broader clinical and research applications.