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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT03053960
Other study ID # 15D.468
Secondary ID
Status Terminated
Phase
First received
Last updated
Start date November 24, 2015
Est. completion date November 1, 2018

Study information

Verified date December 2019
Source Thomas Jefferson University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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 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.


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.


Recruitment information / eligibility

Status Terminated
Enrollment 8
Est. completion date November 1, 2018
Est. primary completion date November 1, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years to 90 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Device:
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
Procedure:
Therapeutic Conventional Surgery
Undergo resection of tumor
Histopathologic Examination
Correlative studies

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Sidney Kimmel Cancer Center at Thomas Jefferson University

Outcome

Type Measure Description Time frame Safety issue
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 Up to 2 years
Secondary Incidence of Sparing Resection Up to 2 years
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