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

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ClinicalTrials.gov Identifier: NCT03053960
Recruitment Status : Active, not recruiting
First Posted : February 15, 2017
Last Update Posted : April 25, 2019
Sponsor:
Information provided by (Responsible Party):
Thomas Jefferson University ( Sidney Kimmel Cancer Center at Thomas Jefferson University )

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.

Condition or disease Intervention/treatment
Oral Cavity Squamous Cell Carcinoma 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

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.


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Study Type : Observational
Estimated Enrollment : 20 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Predictability of Carcinomatous Invasion of the Maxilla or Mandible: An Assessment of Radiologic Modalities With Histologic Correlation
Actual Study Start Date : November 24, 2015
Estimated Primary Completion Date : January 2020
Estimated Study Completion Date : January 2021

Resource links provided by the National Library of Medicine


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 Scan
  • Computerized Axial Tomography
  • CAT

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 Name: Histopathologic Study




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Incidence of sparing resection [ Time Frame: Up to 2 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03053960


Sponsors and Collaborators
Sidney Kimmel Cancer Center at Thomas Jefferson University
Investigators
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Principal Investigator: Lionel Gold, MD Sidney Kimmel Cancer Center at Thomas Jefferson University

Additional Information:
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Responsible Party: Sidney Kimmel Cancer Center at Thomas Jefferson University
ClinicalTrials.gov Identifier: NCT03053960     History of Changes
Other Study ID Numbers: 15D.468
First Posted: February 15, 2017    Key Record Dates
Last Update Posted: April 25, 2019
Last Verified: April 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Carcinoma, Squamous Cell
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell