open access publication

Article, 2024

Comparison of Transoral and Transcervical Ultrasonography with MRI for the Diagnostic Work-Up of Oropharynx Tumors: A Protocol for a Multicenter Clinical Trial (SPOTUS)

Diagnostics, ISSN 2075-4418, Volume 14, 6, Page 577, 10.3390/diagnostics14060577

Contributors

Garset-Zamani, Martin 0000-0003-3857-8003 (Corresponding author) [1] [2] Hvilsom, Gitte Bjørn [3] Kjærgaard, Thomas 0000-0001-5986-5840 [4] Plaschke, Christina Caroline 0000-0002-4284-9040 [2] Hahn, Christoffer Holst [2] Kaltoft, Mikkel 0009-0000-1900-3445 [2] O'Leary, Padraig [4] Frid, Natalie Lassen [3] Norling, Rikke [2] Dejanovic, Danijela [2] Hall, Johanna Maria [2] Agander, Tina Klitmøller [2] Nielsen, Signe Bergliot [4] Ersbøll, Annette Kjær [1] [5] Wessel, Irene 0000-0001-9986-5001 [2] Von Buchwald, Christian 0000-0001-6753-8129 [1] [2] Todsen, Tobias 0000-0003-3267-3560 [1] [2] [6]

Affiliations

  1. [1] University of Copenhagen
    2. [NORA names: KU University of Copenhagen; University; Denmark; Europe, EU; Nordic; OECD];
  2. [2] Rigshospitalet
    3. [NORA names: Capital Region of Denmark; Hospital; Denmark; Europe, EU; Nordic; OECD];
  3. [3] Zealand University Hospital
    4. [NORA names: Region Zealand; Hospital; Denmark; Europe, EU; Nordic; OECD];
  4. [4] Aarhus University Hospital
    5. [NORA names: Central Denmark Region; Hospital; Denmark; Europe, EU; Nordic; OECD];
  5. [5] University of Southern Denmark
    6. [NORA names: SDU University of Southern Denmark; University; Denmark; Europe, EU; Nordic; OECD];

Abstract

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.

Keywords

CT, Cancer Center, FDG, Secondary outcome measures, T stage, Transoral, accuracy, cancer, center, clinic, clinical trials, clinical work-up, clinical work-up of patients, clinically impactful information, comparison, cross-sectional imaging, diagnostic accuracy, diagnostic work-up, diagnostics, estimation, head and neck cancer centers, histopathology, images, impact information, information, integration, magnetic resonance imaging, measurements, multicenter, multicenter clinical trial, multicenter study, negative predictive value, oropharyngeal cancer, oropharyngeal tumors, oropharynx tumors, outcome measures, outcomes, patients, positron, positron emission tomography/computerized tomography, predictive value, primary tumor, protocol, resonance imaging, sensitivity, size, size estimation, specificity, study, study protocol, sub-analysis, tertiary head and neck cancer centers, tomography, transcervical ultrasonography, transcervically, trials, tumor, tumor size estimation, ultrasonography, values, work-up of patients

Funders

  • Novo Nordisk Foundation

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