TY - JOUR
T1 - Comparison of Transoral and Transcervical Ultrasonography with MRI for the Diagnostic Work-Up of Oropharynx Tumors
T2 - A Protocol for a Multicenter Clinical Trial (SPOTUS)
AU - Garset-Zamani, Martin
AU - Hvilsom, Gitte Bjørn
AU - Kjærgaard, Thomas
AU - Plaschke, Christina Caroline
AU - Hahn, Christoffer Holst
AU - Kaltoft, Mikkel
AU - O'Leary, Padraig
AU - Frid, Natalie Lassen
AU - Norling, Rikke
AU - Dejanovic, Danijela
AU - Hall, Johanna Maria
AU - Agander, Tina Klitmøller
AU - Nielsen, Signe Bergliot
AU - Ersbøll, Annette Kjær
AU - Wessel, Irene
AU - Buchwald, Christian von
AU - Todsen, Tobias
PY - 2024/3/8
Y1 - 2024/3/8
N2 - 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.
AB - 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.
U2 - 10.3390/diagnostics14060577
DO - 10.3390/diagnostics14060577
M3 - Protocol
C2 - 38534997
SN - 2075-4418
VL - 14
JO - Diagnostics
JF - Diagnostics
IS - 6
ER -