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| ID | Type | Description | Link |
|---|---|---|---|
| JT 6307 | Other Identifier | JeffTrial Number |
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Terminated by IRB
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Diagnostic (helical CT, PET/CT, MRI, CBCT) | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Computed Tomography | Device | Undergo helical CT scan |
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| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Sparing Resection | Up to 2 years |
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Inclusion Criteria:
Exclusion Criteria:
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The data from all of the subjects that are enrolled and have consented to be a part of the study will be analyzed
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| Name | Affiliation | Role |
|---|---|---|
| Lionel Gold, MD | Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University | Principal Investigator |
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| Label | URL |
|---|---|
| Sidney Kimmel Cancer Center | View source |
| Thomas Jefferson University Hospital | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Diagnostic (Helical CT, PET/CT, MRI, CBCT) | 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. Computed Tomography: Undergo helical CT scan Positron Emission Tomography and Computed Tomography Scan: Undergo PET/CT scan Cone-Beam Computed Tomography: Undergo CBCT scan Magnetic Resonance Imaging: Undergo MRI scan Therapeutic Conventional Surgery: Undergo resection of tumor Histopathologic Examination: Correlative studies |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 23, 2016 |
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| Positron Emission Tomography and Computed Tomography Scan | Device | Undergo PET/CT scan |
|
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| Cone-Beam Computed Tomography | Device | Undergo CBCT scan |
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| Magnetic Resonance Imaging | Device | Undergo MRI scan |
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| Therapeutic Conventional Surgery | Procedure | Undergo resection of tumor |
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| Histopathologic Examination | Procedure | Correlative studies |
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| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Diagnostic (Helical CT, PET/CT, MRI, CBCT) | 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. Computed Tomography: Undergo helical CT scan Positron Emission Tomography and Computed Tomography Scan: Undergo PET/CT scan Cone-Beam Computed Tomography: Undergo CBCT scan Magnetic Resonance Imaging: Undergo MRI scan Therapeutic Conventional Surgery: Undergo resection of tumor Histopathologic Examination: Correlative studies |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | The study was terminated by the IRB. Sincere efforts were made to gather and report the data, however, no data is available for the study. | Posted | Up to 2 years |
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| Secondary | Incidence of Sparing Resection | The study was terminated by the IRB. Sincere efforts were made to gather and report the data, however, no data is available for the study. | Posted | Up to 2 years |
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baseline to 30 days after completion of study treatment
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Diagnostic (Helical CT, PET/CT, MRI, CBCT) | 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. Computed Tomography: Undergo helical CT scan Positron Emission Tomography and Computed Tomography Scan: Undergo PET/CT scan Cone-Beam Computed Tomography: Undergo CBCT scan Magnetic Resonance Imaging: Undergo MRI scan Therapeutic Conventional Surgery: Undergo resection of tumor Histopathologic Examination: Correlative studies | 0 | 8 | 0 | 8 | 0 | 8 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Lionel Gold | Sidney Kimmel Cancer Center at Thomas Jefferson University | 215-955-6215 | Lionel.Gold@jefferson.edu |
| Nov 21, 2019 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D000077195 | Squamous Cell Carcinoma of Head and Neck |
| ID | Term |
|---|---|
| D002294 | Carcinoma, Squamous Cell |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D009371 | Neoplasms by Site |
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| ID | Term |
|---|---|
| D014057 | Tomography, X-Ray Computed |
| D000072078 | Positron Emission Tomography Computed Tomography |
| D054893 | Cone-Beam Computed Tomography |
| D008279 | Magnetic Resonance Imaging |
| ID | Term |
|---|---|
| D007090 | Image Interpretation, Computer-Assisted |
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D011856 | Radiographic Image Enhancement |
| D007089 | Image Enhancement |
| D010781 | Photography |
| D011859 | Radiography |
| D014056 | Tomography, X-Ray |
| D014054 | Tomography |
| D049268 | Positron-Emission Tomography |
| D014055 | Tomography, Emission-Computed |
| D064847 | Multimodal Imaging |
| D011877 | Radionuclide Imaging |
| D003947 | Diagnostic Techniques, Radioisotope |
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| Unknown or Not Reported |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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