Trial Outcomes & Findings for Helical CT, PET/CT, MRI, and CBCT Alone or in Combination in Predicting Jaw Invasion in Patients With Oral Cancer (NCT NCT03053960)
NCT ID: NCT03053960
Last Updated: 2025-04-30
Results Overview
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
TERMINATED
8 participants
Up to 2 years
2025-04-30
Participant Flow
Participant milestones
| Measure |
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
|
|---|---|
|
Overall Study
STARTED
|
8
|
|
Overall Study
COMPLETED
|
8
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Helical CT, PET/CT, MRI, and CBCT Alone or in Combination in Predicting Jaw Invasion in Patients With Oral Cancer
Baseline characteristics by cohort
| Measure |
Diagnostic (Helical CT, PET/CT, MRI, CBCT)
n=8 Participants
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
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
5 Participants
n=99 Participants
|
|
Age, Categorical
>=65 years
|
3 Participants
n=99 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
8 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
7 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
8 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: Up to 2 yearsPopulation: 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.
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
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 2 yearsPopulation: 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.
Outcome measures
Outcome data not reported
Adverse Events
Diagnostic (Helical CT, PET/CT, MRI, CBCT)
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Lionel Gold
Sidney Kimmel Cancer Center at Thomas Jefferson University
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place