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
:1. Introduction
Research Question
2. Materials and Methods
2.1. Study Design and Setting
2.2. Participant Eligibility
2.3. Outpatient-Performed Clinical Exam with Transoral and Transcervical US (Index Test)
2.3.1. Standard Clinical Work-Up
2.3.2. Prospective Clinical Data Collection during Initial Outpatient Clinic Exam
Setting | Standard Diagnostic Work-Up | Study Interventions |
---|---|---|
Otorhinolaryngology, Head and Neck Surgery outpatient clinic (Initial work-up) |
|
|
Diagnostic imaging |
| |
Diagnostic operations |
| |
MDT conference and treatment-initiation planning |
|
2.3.3. Transoral and Transcervical US Training
2.3.4. Outpatient-Performed Transoral US
2.3.5. Outpatient-Performed Transcervical US
2.3.6. US Criteria for Tumor Detection
2.3.7. US Tumor Size Estimation and T-Staging
2.4. Cross-Sectional Imaging (Comparison Tests)
2.5. Reference Standard for Tumor Detection
3. Outcome Definitions
3.1. Primary Outcomes
3.2. Secondary Outcomes
- Oropharyngeal tumor suspicion via US, MRI, PET/CT, and CT (5-point Likert scale).
- Detection of patients suspected to have unknown primary OPSCCs via transoral and transcervical US, MRI, and PET/CT.
- Tumor detection, size (mm) in three dimensions (craniocaudal, anteroposterior, and mediolateral), and volume (mm3) estimated clinically via US, MRI, CT, and histopathology.
- Categorical T-stage (Tx, T0, T1, T2, T3, or T4) measured clinically via US, MRI, and CT.
3.3. Other Outcomes
- Scan quality of transoral US, transcervical US, MRI, PET/CT, and CT (5-point Likert scale).
- Patient mouth opening ability (mm) and categorical trismus (>35 mm, ≤35 mm).
- An 11-point numeric rating scale for discomfort of oropharyngeal palpation and transoral US.
- Patient gagging severity index (5-point scale).
- Patient Mallampati score (grade I-IV).
4. Statistics
5. Sample Size Calculation
6. Discussion
Supplementary Materials
Author Contributions
Funding
Institutional Review Board Statement
Informed Consent Statement
Data Availability Statement
Acknowledgments
Conflicts of Interest
Abbreviations
95%CI | 95% Confidence interval | MPM | Medial pterygoid muscle |
BOT | Base of tongue | MRI | Magnetic resonance imaging |
CT | Computerized tomography | OPSCC | Oropharyngeal squamous cell carcinoma |
FDG | 18F-Fluorodeoxyglucose | PET/CT | Positron emission tomography/computerized tomography |
GEE | Generalized estimating equations | PT | Palatine tonsil |
GGM | Genioglossus muscle | SGM | Styloglossus muscle |
GHM | Geniohyoid muscle | SMG | Submandibular gland |
HPV | Human papillomavirus | SPM | Stylopharyngeus muscle |
ICA | Internal carotid artery | SPOT-US | Surgeon-Performed Oropharyngeal Transoral UltraSonography |
ITM | Intrinsic tongue muscles | UICC8 | Union for International Cancer Control 8th Edition |
MDT | Multidisciplinary team | US | Ultrasonography |
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Screen ID | Age | Sex | Clinical Diagnosis | Offered Inclusion | Reasons Not Included | Excluded | Reasons for Exclusion | Final Histopathology Diagnosis | Final Tumor Location | Final T-Stage |
---|---|---|---|---|---|---|---|---|---|---|
Suspected oropharynx tumor or unknown primary cancer | Yes, No | Declined, Missed, Other | Yes, No | Inclusion/exclusion criteria not met | No tumor, Squamous cell carcinoma, Benign tumor, Lymphoma, Other | Palatine tonsil, Lingual tonsil, Other oropharynx, Unknown, Other head and neck tumor. | Tx, T0, T1, T2, T3, T4 |
Criteria | Description |
---|---|
Inclusion |
|
Exclusion |
|
Test Result | Oropharyngeal Tumor | No Oropharyngeal Tumor |
---|---|---|
Positive or inconclusive, correct location | TP | FP |
Positive or inconclusive, wrong location | FN | FP |
Negative | FN | TN |
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Share and Cite
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.; et al. 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 2024, 14, 577. https://doi.org/10.3390/diagnostics14060577
Garset-Zamani M, Hvilsom GB, Kjærgaard T, Plaschke CC, Hahn CH, Kaltoft M, O’Leary P, Frid NL, Norling R, Dejanovic D, et al. 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. 2024; 14(6):577. https://doi.org/10.3390/diagnostics14060577
Chicago/Turabian StyleGarset-Zamani, Martin, Gitte Bjørn Hvilsom, Thomas Kjærgaard, Christina Caroline Plaschke, Christoffer Holst Hahn, Mikkel Kaltoft, Padraig O’Leary, Natalie Lassen Frid, Rikke Norling, Danijela Dejanovic, and et al. 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, no. 6: 577. https://doi.org/10.3390/diagnostics14060577
APA StyleGarset-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), 577. https://doi.org/10.3390/diagnostics14060577