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

Terminated

Conditions: Oral Cavity Squamous Cell Carcinoma

Interventions: 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

Registration Number: NCT03053960

Lead Sponsor: Sidney Kimmel Cancer Center at Thomas Jefferson University

Brief Summary: 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: 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.

Recruitment & Eligibility

Status: TERMINATED

Sex: All

Target Recruitment: 8

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

Study & Design

Study Type: OBSERVATIONAL

Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Diagnostic (helical CT, PET/CT, MRI, CBCT)	Cone-Beam Computed Tomography	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.
Diagnostic (helical CT, PET/CT, MRI, CBCT)	Computed Tomography	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.
Diagnostic (helical CT, PET/CT, MRI, CBCT)	Histopathologic Examination	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.
Diagnostic (helical CT, PET/CT, MRI, CBCT)	Positron Emission Tomography and Computed Tomography Scan	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.
Diagnostic (helical CT, PET/CT, MRI, CBCT)	Magnetic Resonance Imaging	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.
Diagnostic (helical CT, PET/CT, MRI, CBCT)	Therapeutic Conventional Surgery	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.

Primary Outcome Measures

Name	Time	Method
Accurate Predication of the Presence or Absence of Bone Invasion by Oral Squamous Cell Carcinoma by Helical CT, PET/CT, MRI and CBCT	Up to 2 years	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

Secondary Outcome Measures