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

April 28, 2025 updated by: Sidney Kimmel Cancer Center at Thomas Jefferson University

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

8

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
Device: Computed Tomography
Undergo helical CT scan
Other Names:
  • CAT
  • CAT Scan
  • Computerized Axial Tomography
Device: Positron Emission Tomography and Computed Tomography Scan
Undergo PET/CT scan
Other Names:
  • PET-CT Scan
  • PET/CT SCAN
Device: Cone-Beam Computed Tomography
Undergo CBCT scan
Device: Magnetic Resonance Imaging
Undergo MRI scan
Other Names:
  • MRI
  • MRI Scan
Procedure: Therapeutic Conventional Surgery
Undergo resection of tumor
Procedure: Histopathologic Examination
Correlative studies
Other Names:
  • Histopathologic Study

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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
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
Up to 2 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Incidence of Sparing Resection
Time Frame: Up to 2 years
Up to 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sidney Kimmel Cancer Center at Thomas Jefferson University

Investigators

  • Principal Investigator: Lionel Gold, MD, Sidney Kimmel Cancer Center at Thomas Jefferson University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 24, 2015

Primary Completion (Actual)

November 1, 2018

Study Completion (Actual)

November 1, 2018

Study Registration Dates

First Submitted

January 31, 2017

First Submitted That Met QC Criteria

February 10, 2017

First Posted (Actual)

February 15, 2017

Study Record Updates

Last Update Posted (Actual)

April 30, 2025

Last Update Submitted That Met QC Criteria

April 28, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 15D.468
  • JT 6307 (Other Identifier: JeffTrial Number)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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