Oral Cavity Squamous Cell CarcinomaNCT03053960
Helical CT, PET/CT, MRI, and CBCT Alone or in Combination in Predicting Jaw Invasion in Patients With Oral Cancer
An observational study of Oral Cavity Squamous Cell Carcinoma, run by Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Oral Cavity Squamous Cell Carcinoma
- What is being tested?
- Computed Tomography, Positron Emission Tomography and Computed Tomography Scan and Cone-Beam Computed Tomography
- Type of treatment
- Medical device, Surgery or procedure
- How many people
- 8 participants
- Where
- No sites listed yet
- Study dates
- 24 Nov 2015to 1 Nov 2018
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The data from all of the subjects that are enrolled and have consented to be a part of the study will be analyzed
Who may be able to join
- Diagnosis of squamous cell carcinoma of the oral cavity
- Able to read and sign and informed consent
Who cannot join
- Prior mandibular surgery
- Primary intraosseous carcinoma
- Prior history of radiation to the mandible
- Obvious finding of clinical invasion of the mandible
About this study
Official title: Predictability of Carcinomatous Invasion of the Maxilla or Mandible: An Assessment of Radiologic Modalities With Histologic Correlation
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.
Read the detailed description
PRIMARY OBJECTIVES:
- 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:
- To compare the histopathologic findings to the radiologic findings.
- Conditions
- Oral Cavity Squamous Cell Carcinoma
- Being tested
- Computed Tomography, Positron Emission Tomography and Computed Tomography Scan, Cone-Beam Computed Tomography, Magnetic Resonance Imaging, Therapeutic Conventional Surgery
- Medical subject headings
- Squamous Cell Carcinoma of Head and Neck
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Computed TomographyDevice
Also called CAT Scan, Computerized Axial Tomography, CAT
Undergo helical CT scan
Positron Emission Tomography and Computed Tomography ScanDevice
Also called PET-CT Scan, PET/CT SCAN
Undergo PET/CT scan
Cone-Beam Computed TomographyDevice
Undergo CBCT scan
Magnetic Resonance ImagingDevice
Also called MRI, MRI Scan
Undergo MRI scan
Therapeutic Conventional SurgeryProcedure or surgery
Undergo resection of tumor
Histopathologic ExaminationProcedure or surgery
Also called Histopathologic Study
Correlative studies
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Up to 2 years
Secondary outcomes (1)
Incidence of Sparing Resection
Measured: Up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2017
- Study start24 Nov 2015
- Primary completion1 Nov 2018
- Study completion1 Nov 2018
Why it stopped: Terminated by IRB
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Oral Cavity Squamous Cell CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lionel Gold, MD, Principal investigator, Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03053960
- Sponsor's protocol ID
- 15D.468
- Other IDs
- JT 6307
- Status last verified
- Apr 2025
- First submitted
- 31 Jan 2017
- Last updated
- 30 Apr 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictability of Carcinomatous Invasion of the Maxilla or Mandible: An Assessment of Radiologic Modalities With Histologic Correlation
- ClinicalTrials.gov ID
- NCT03053960
- Acronym / sponsor ID
- 15D.468
- Conditions
- Oral Cavity Squamous Cell Carcinoma
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Terminated by IRB
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson UniversityUniversity, hospital or other
- Study start
- 24 Nov 2015 (actual)
- Primary completion
- 1 Nov 2018 (actual)
- Study completion
- 1 Nov 2018 (actual)
- First posted
- 15 Feb 2017 (actual)
- Results
- Posted 18 Dec 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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:
- To compare the histopathologic findings to the radiologic findings.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Diagnostic (helical CT, PET/CT, MRI, CBCT) | – | 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 ExaminationPatients 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. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The data from all of the subjects that are enrolled and have consented to be a part of the study will be analyzed
Key inclusion criteria (2 listed)
- Diagnosis of squamous cell carcinoma of the oral cavity
- Able to read and sign and informed consent
Key exclusion criteria (4 listed)
- Prior mandibular surgery
- Primary intraosseous carcinoma
- Prior history of radiation to the mandible
- Obvious finding of clinical invasion of the mandible
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Computed TomographyAlso: CAT Scan, Computerized Axial Tomography, CATUndergo helical CT scan | Device | Diagnostic (helical CT, PET/CT, MRI, CBCT) |
| Positron Emission Tomography and Computed Tomography ScanAlso: PET-CT Scan, PET/CT SCANUndergo PET/CT scan | Device | Diagnostic (helical CT, PET/CT, MRI, CBCT) |
| Cone-Beam Computed TomographyUndergo CBCT scan | Device | Diagnostic (helical CT, PET/CT, MRI, CBCT) |
| Magnetic Resonance ImagingAlso: MRI, MRI ScanUndergo MRI scan | Device | Diagnostic (helical CT, PET/CT, MRI, CBCT) |
| Therapeutic Conventional SurgeryUndergo resection of tumor | Procedure or surgery | Diagnostic (helical CT, PET/CT, MRI, CBCT) |
| Histopathologic ExaminationAlso: Histopathologic StudyCorrelative studies | Procedure or surgery | Diagnostic (helical CT, PET/CT, MRI, CBCT) |
Primary outcome
Accurate Predication of the Presence or Absence of Bone Invasion by Oral Squamous Cell Carcinoma by Helical CT, PET/CT, MRI and CBCT
Time frame: 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
1 secondary outcome
Incidence of Sparing Resection
Time frame: Up to 2 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Sidney Kimmel Cancer CenterLink provided by the sponsor.
- Thomas Jefferson University HospitalLink provided by the sponsor.
Related trials for Oral Cavity Squamous Cell Carcinoma
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingPhase 2
Proton Spatially Fractionated Radiotherapy or Photon Stereotactic Body Radiotherapy in Combination With Pembrolizumab Before Surgery for the Treatment of Locally Advanced and Radiation-Naive Locoregionally Recurrent Oral Cavity Cancer, OSPRI Trial
Locally Advanced Oral Cavity Squamous Cell Carcinoma, Locally Recurrent Oral Cavity Squamous Cell Carcinoma
RecruitingObservational study
Defining the Natural History of Squamous Cell Carcinoma in Fanconi Anemia
Fanconi Anemia, Inherited Bone Marrow Failure Syndrome
RecruitingPhase 1/2
Docetaxel and SX-682 in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma, Salivary Gland Carcinoma, and Advanced Prostate Cancer
Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma
RecruitingPhase 3
Testing the Addition of Anti-Cancer Drug, Cetuximab, to Standard of Care Treatment (Pembrolizumab) for Returning or Spreading Head and Neck Cancer After Previous Treatment
Metastatic Head and Neck Squamous Cell Carcinoma, Metastatic Hypopharyngeal Squamous Cell Carcinoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lionel Gold, MD principal investigator
Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University
Questions about this trial
What is this clinical trial studying?
An observational study of Oral Cavity Squamous Cell Carcinoma, run by Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 30 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Dec 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accurate Predication of the Presence or Absence of Bone Invasion by Oral Squamous Cell Carcinoma by Helical CT, PET/CT, MRI and CBCT (time frame: Up to 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2025.