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

doi:10.3390/diagnostics14060577

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

^*Corresponding author for this work

Department of Clinical Medicine - The Department of Oto-Rhino-Laryngology

Research output: Contribution to journal/Conference contribution in journal/Contribution to newspaper › Journal article › Research › peer-review

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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.

Original language	English
Article number	577
Journal	Diagnostics
Volume	14
Issue	6
Number of pages	14
ISSN	2075-4418
DOIs	https://doi.org/10.3390/diagnostics14060577
Publication status	Published - Mar 2024

Keywords

base of tongue
human papillomavirus
intraoral ultrasound
lingual tonsil
oropharyngeal cancer
oropharyngeal squamous cell carcinoma
palatine tonsil
tonsil cancer
transcervical ultrasound
transoral ultrasound

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Garset-Zamani, M., Hvilsom, G. B., Kjærgaard, T., Plaschke, C. C., Hahn, C. H., Kaltoft, M., O’Leary, P., Frid, N. L., Norling, R., Dejanovic, D., Hall, J. M., Agander, T. K., Nielsen, S. B., Ersbøll, A. K., Wessel, I., Buchwald, C. V., & Todsen, T. (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, 14(6), Article 577. https://doi.org/10.3390/diagnostics14060577

@article{808021b0a166477b8974182c9659ef8e,

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

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 = "base of tongue, human papillomavirus, intraoral ultrasound, lingual tonsil, oropharyngeal cancer, oropharyngeal squamous cell carcinoma, palatine tonsil, tonsil cancer, transcervical ultrasound, transoral ultrasound",

author = "Martin Garset-Zamani and Hvilsom, {Gitte Bj{\o}rn} and Thomas Kj{\ae}rgaard and Plaschke, {Christina Caroline} and Hahn, {Christoffer Holst} and Mikkel Kaltoft and Padraig O{\textquoteright}Leary and Frid, {Natalie Lassen} and Rikke Norling and Danijela Dejanovic and Hall, {Johanna Maria} and Agander, {Tina Klitm{\o}ller} and Nielsen, {Signe Bergliot} and Ersb{\o}ll, {Annette Kj{\ae}r} and Irene Wessel and Buchwald, {Christian von} and Tobias Todsen",

note = "Publisher Copyright: {\textcopyright} 2024 by the authors.",

year = "2024",

month = mar,

doi = "10.3390/diagnostics14060577",

language = "English",

volume = "14",

journal = "Diagnostics",

issn = "2075-4418",

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Garset-Zamani, M, Hvilsom, GB, Kjærgaard, T, Plaschke, CC, Hahn, CH, Kaltoft, M, O’Leary, P, Frid, NL, Norling, R, Dejanovic, D, Hall, JM, Agander, TK, Nielsen, SB, Ersbøll, AK, Wessel, I, Buchwald, CV & Todsen, T 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, vol. 14, no. 6, 577. https://doi.org/10.3390/diagnostics14060577

Comparison of Transoral and Transcervical Ultrasonography with MRI for the Diagnostic Work-Up of Oropharynx Tumors: A Protocol for a Multicenter Clinical Trial (SPOTUS). / Garset-Zamani, Martin; Hvilsom, Gitte Bjørn; Kjærgaard, Thomas et al.
In: Diagnostics, Vol. 14, No. 6, 577, 03.2024.

Research output: Contribution to journal/Conference contribution in journal/Contribution to newspaper › Journal article › Research › peer-review

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

Y1 - 2024/3

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.

KW - base of tongue

KW - human papillomavirus

KW - intraoral ultrasound

KW - lingual tonsil

KW - oropharyngeal cancer

KW - oropharyngeal squamous cell carcinoma

KW - palatine tonsil

KW - tonsil cancer

KW - transcervical ultrasound

KW - transoral ultrasound

UR - http://www.scopus.com/inward/record.url?scp=85189165329&partnerID=8YFLogxK

U2 - 10.3390/diagnostics14060577

DO - 10.3390/diagnostics14060577

M3 - Journal article

C2 - 38534997

AN - SCOPUS:85189165329

SN - 2075-4418

VL - 14

JO - Diagnostics

JF - Diagnostics

IS - 6

M1 - 577

ER -

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

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Keywords

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