Modern Hybrid Imaging in Patients With OSCC

Study Overview
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Brief Summary
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Prospective diagnostic study to determine the diagnostic accuracy of preoperative 18F--fluorodeoxyglucose (FDG) positron emission tomography/computed tomography (PET/CT) in detecting local tumor extent, cervical lymph node metastases and distant metastases/secondary primary tumor.

Official Title
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Modern Hybrid Imaging for Staging and Monitoring Patients With Oral Squamous Cell Carcinoma

Conditions
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Neoplasm

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Histopathological proven head and neck carcinoma Written inform consent 18 years of age Exclusion Criteria: Cancer of unknown primary En-bloc resection of lymph node levels Uncertainties regarding the removed lymph node levels

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnostic accuracy of FGD-PET/CT to detect the primary tumor | Visual assessment of FDG-PET/CT will be performed according to current guidelines. The localization, expansion, and infiltration of osseous structures will be recorded. The outcome measure is the correct diagnosis (1 = correct; 0 = false) with regards to the histopathological analysis. The outcome measure will then be used to calculate the diagnostic accuracy of FDG-PET/CT to detect the primary tumor. | 2013-2018 | 
| Diagnostic accuracy of FGD-PET/CT to detect lymph nodes metastases | Visual assessment of FDG-PET/CT will be performed according to current guidelines. The presence and number of nodal metastasis will be recorded for each cervical lymph node level. The outcome measure is the correct diagnosis (1 = correct; 0 = false) with regards to the histopathological analysis. The analysis will be performed on a patient level (lymph node metastasis yes/no), on the nodal metastatic involvement of cervical sides and lymph node levels. The outcome measure will then be used to calculate the diagnostic accuracy of FDG-PET/CT to detect lymph node metastases. | 2013-2018 | 
| Diagnostic accuracy of FGD-PET/CT to detect distant lymph node metastases. | Visual assessment of FDG-PET/CT will be performed according to current guidelines. The presence, localization and number of distant nodal metastasis will be recorded. The outcome measure is the correct diagnosis (1 = correct; 0 = false) with regards to the histopathological analysis. The outcome measure will then be used to calculate the diagnostic accuracy of FDG-PET/CT to detect lymph node metastases. | 2013-2018 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnostic accuracy of MRI to detect the primary tumor | Visual assessment of MRI will be performed according to current guidelines. The localization, expansion, and infiltration of osseous structures will be recorded. The outcome measure is the correct diagnosis (1 = correct; 0 = false) with regards to the histopathological analysis. The outcome measure will then be used to calculate the diagnostic accuracy of MRI to detect the primary tumor. | 2013-2018 | 
| Diagnostic accuracy of MRI to detect lymph nodes metastases | Visual assessment of MRI will be performed according to current guidelines. The presence and number of nodal metastasis will be recorded for each cervical lymph node level. The outcome measure is the correct diagnosis (1 = correct; 0 = false) with regards to the histopathological analysis. The analysis will be performed on a patient level (lymph node metastasis yes/no), on the nodal metastatic involvement of cervical sides and lymph node levels. The outcome measure will then be used to calculate the diagnostic accuracy of MRI to detect lymph node metastases. | 2013-2018 | 
| Diagnostic accuracy of CT to detect the primary tumor | Visual assessment of CT will be performed according to current guidelines. The localization, expansion, and infiltration of osseous structures will be recorded. The outcome measure is the correct diagnosis (1 = correct; 0 = false) with regards to the histopathological analysis. The outcome measure will then be used to calculate the diagnostic accuracy of CT to detect the primary tumor. | 2013-2018 | 
| Diagnostic accuracy of CT to detect lymph nodes metastases | Visual assessment of CT will be performed according to current guidelines. The presence and number of nodal metastasis will be recorded for each cervical lymph node level. The outcome measure is the correct diagnosis (1 = correct; 0 = false) with regards to the histopathological analysis. The analysis will be performed on a patient level (lymph node metastasis yes/no), on the nodal metastatic involvement of cervical sides and lymph node levels. The outcome measure will then be used to calculate the diagnostic accuracy of CT to detect lymph node metastases. | 2013-2018 | 
| Diagnostic accuracy of CT to detect distant lymph node metastases. | Visual assessment of CT will be performed according to current guidelines. The presence, localization and number of distant nodal metastasis will be recorded. The outcome measure is the correct diagnosis (1 = correct; 0 = false) with regards to the histopathological analysis. The outcome measure will then be used to calculate the diagnostic accuracy of CT to detect lymph node metastases. | 2013-2018 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Head and Neck, SCC, PET/CT, Staging