Helical CT, PET/CT, MRI, and CBCT Alone or in Combination in Predicting Jaw Invasion in Patients With Oral Cancer

Study Overview
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Brief Summary
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This clinical trial studies how well helical computed tomography (CT), positron emission tomography (PET)/CT, magnetic resonance imaging (MRI), and cone beam computed tomography (CBCT) work alone or in combination in predicting whether tumor cells have spread to the jaw bone (jaw invasion) in patients with oral cancer. Imaging, such as helical CT, PET/CT, MRI, and CBCT, may help find out how far cancer has spread. Accurate prediction of the presence or absence of jaw invasion may help create a better surgical treatment plan for patients with oral cancer.

Detailed Description
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PRIMARY OBJECTIVES: I. To determine which imaging modality or combination of imaging methods, in conjunction with clinical and histological examination, will most accurately predict the presence or absence of invasion of the mandible or maxilla by intraoral squamous cell carcinoma (SCC). SECONDARY OBJECTIVES: I. To compare the histopathologic findings to the radiologic findings.

Official Title
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Predictability of Carcinomatous Invasion of the Maxilla or Mandible: An Assessment of Radiologic Modalities With Histologic Correlation

Conditions
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Oral Cavity Squamous Cell Carcinoma

Intervention / Treatment
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* Device: Computed Tomography
* Device: Positron Emission Tomography and Computed Tomography Scan
* Device: Cone-Beam Computed Tomography
* Device: Magnetic Resonance Imaging
* Procedure: Therapeutic Conventional Surgery
* Procedure: Histopathologic Examination


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of squamous cell carcinoma of the oral cavity Able to read and sign and informed consent Exclusion Criteria: Prior mandibular surgery Primary intraosseous carcinoma Prior history of radiation to the mandible Obvious finding of clinical invasion of the mandible

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Diagnostic (helical CT, PET/CT, MRI, CBCT)<br>Patients undergo helical (Computed Tomography) CT,(Positron Emission Tomography and Computed Tomography) PET/CT, (Magnetic Resonance Imaging) MRI, and (Cone-Beam Computed Tomography) CBCT scans. Patients also undergo therapeutic conventional surgical resection of tumor. | Device: Computed Tomography<br>* Undergo helical CT scan<br>* Other names: CAT;Device: Positron Emission Tomography and Computed Tomography Scan<br>* Undergo PET/CT scan<br>* Other names: PET/CT SCAN;Device: Cone-Beam Computed Tomography<br>* Undergo CBCT scan<br>Device: Magnetic Resonance Imaging<br>* Undergo MRI scan<br>* Other names: MRI Scan;Procedure: Therapeutic Conventional Surgery<br>* Undergo resection of tumor<br>Procedure: Histopathologic Examination<br>* Correlative studies<br>* Other names: Histopathologic Study;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Accurate Predication of the Presence or Absence of Bone Invasion by Oral Squamous Cell Carcinoma by Helical CT, PET/CT, MRI and CBCT | Sensitivity and specificity of the clinical exam, CBCT, helical CT, PET/CT, MRI and any other imaging modality used in detection of bone invasion will be calculated, as compared to the histological examination of the specimens. The positive and negative predictive value will be calculated for each modality using the true positive and negatives as well as false positive and negative values | Up to 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Sparing Resection |  | Up to 2 years |