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

Oral Cavity Squamous Cell Carcinoma Clinical Trial

Official title:

Predictability of Carcinomatous Invasion of the Maxilla or Mandible: An Assessment of Radiologic Modalities With Histologic Correlation

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03053960
• Other study ID #: 15D.468
• Status: Terminated
• 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
• 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

Related Conditions & MeSH terms

• Carcinoma, Squamous Cell
• Oral Cavity Squamous Cell Carcinoma

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

External Links

•   Sidney Kimmel Cancer Center
•   Thomas Jefferson University Hospital