Oral Cavity Squamous Cell Carcinoma
Conditions
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.
Interventions
DEVICEComputed Tomography
Undergo helical CT scan
Undergo PET/CT scan
DEVICECone-Beam Computed Tomography
Undergo CBCT scan
DEVICEMagnetic Resonance Imaging
Undergo MRI scan
PROCEDURETherapeutic Conventional Surgery
Undergo resection of tumor
PROCEDUREHistopathologic Examination
Correlative studies
Sponsors
Sidney Kimmel Cancer Center at Thomas Jefferson University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame |
|---|---|
| Incidence of Sparing Resection | Up to 2 years |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 8 |
| Total | 8 |
Baseline characteristics
| Characteristic | Diagnostic (Helical CT, PET/CT, MRI, CBCT) |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 3 Participants |
| Age, Categorical Between 18 and 65 years | 5 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 8 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 7 Participants |
| Region of Enrollment United States | 8 participants |
| Sex: Female, Male Female | 3 Participants |
| Sex: Female, Male Male | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 8 |
| other Total, other adverse events | 0 / 8 |
| serious Total, serious adverse events | 0 / 8 |
Outcome results
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
Time frame: Up to 2 years
Population: 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.
Secondary
Incidence of Sparing Resection
Time frame: Up to 2 years
Population: 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.