Comparison of Transoral and Transcervical Ultrasonography with MRI for the Diagnostic Work-Up of Oropharynx Tumors: A Protocol for a Multicenter Clinical Trial (SPOTUS)
Martin Garset-Zamani,
Gitte Bjørn Hvilsom,
Thomas Kjærgaard,
Christina Caroline Plaschke,
Christoffer Holst Hahn,
Mikkel Kaltoft,
Padraig O’Leary,
Natalie Lassen Frid,
Rikke Norling,
Danijela Dejanovic,
Johanna Maria Hall,
Tina Klitmøller Agander,
Signe Bergliot Nielsen,
Annette Kjær Ersbøll,
Irene Wessel,
Christian von Buchwald,
Tobias Todsen
Affiliations
Martin Garset-Zamani
Department of Otorhinolaryngology, Head and Neck Surgery and Audiology, Copenhagen University Hospital—Rigshospitalet, 2100 Copenhagen, Denmark
Gitte Bjørn Hvilsom
Department of Otorhinolaryngology, Head and Neck Surgery, Zealand University Hospital, 4600 Køge, Denmark
Thomas Kjærgaard
Department of Otorhinolaryngology, Head and Neck Surgery & Audiology, Aarhus University Hospital, 8200 Aarhus, Denmark
Christina Caroline Plaschke
Department of Otorhinolaryngology, Head and Neck Surgery and Audiology, Copenhagen University Hospital—Rigshospitalet, 2100 Copenhagen, Denmark
Christoffer Holst Hahn
Department of Otorhinolaryngology, Head and Neck Surgery and Audiology, Copenhagen University Hospital—Rigshospitalet, 2100 Copenhagen, Denmark
Mikkel Kaltoft
Department of Otorhinolaryngology, Head and Neck Surgery and Audiology, Copenhagen University Hospital—Rigshospitalet, 2100 Copenhagen, Denmark
Padraig O’Leary
Department of Otorhinolaryngology, Head and Neck Surgery & Audiology, Aarhus University Hospital, 8200 Aarhus, Denmark
Natalie Lassen Frid
Department of Otorhinolaryngology, Head and Neck Surgery, Zealand University Hospital, 4600 Køge, Denmark
Rikke Norling
Department of Radiology, Copenhagen University Hospital—Rigshospitalet, 2100 Copenhagen, Denmark
Danijela Dejanovic
Department of Clinical Physiology and Nuclear Medicine, Copenhagen University Hospital—Rigshospitalet, 2100 Copenhagen, Denmark
Johanna Maria Hall
Department of Clinical Physiology and Nuclear Medicine, Copenhagen University Hospital—Rigshospitalet, 2100 Copenhagen, Denmark
Tina Klitmøller Agander
Department of Pathology, Copenhagen University Hospital—Rigshospitalet, 2100 Copenhagen, Denmark
Signe Bergliot Nielsen
Department of Otorhinolaryngology, Head and Neck Surgery & Audiology, Aarhus University Hospital, 8200 Aarhus, Denmark
Annette Kjær Ersbøll
Copenhagen Emergency Medical Services, University of Copenhagen, 2100 Copenhagen, Denmark
Irene Wessel
Department of Otorhinolaryngology, Head and Neck Surgery and Audiology, Copenhagen University Hospital—Rigshospitalet, 2100 Copenhagen, Denmark
Christian von Buchwald
Department of Otorhinolaryngology, Head and Neck Surgery and Audiology, Copenhagen University Hospital—Rigshospitalet, 2100 Copenhagen, Denmark
Tobias Todsen
Department of Otorhinolaryngology, Head and Neck Surgery and Audiology, Copenhagen University Hospital—Rigshospitalet, 2100 Copenhagen, Denmark
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.
