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

• Sponsor: Sidney Kimmel Cancer Center at Thomas Jefferson University (Other)
• Overall Status: Terminated
• CT.gov ID: NCT03053960
• Collaborator: (none)
• Enrollment: 8
• Actual Duration (Months): 35.3

Study Details

Study Description

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	Phase
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:

1. 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:

1. To compare the histopathologic findings to the radiologic findings.

Study Design

• Study Type: Observational
• Actual Enrollment: 8 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: Nov 24, 2015
• Actual Primary Completion Date: Nov 1, 2018
• Actual Study Completion Date: Nov 1, 2018

Arms and Interventions

Arm

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 Names: Histopathologic Study

Outcome Measures

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 [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 [Up to 2 years]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 90 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Sidney Kimmel Cancer Center at Thomas Jefferson University

Investigators

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

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Mar 23, 2016

More Information

Additional Information:

• Sidney Kimmel Cancer Center
• Thomas Jefferson University Hospital

Publications

None provided.

• Responsible Party: Sidney Kimmel Cancer Center at Thomas Jefferson University
• ClinicalTrials.gov Identifier: NCT03053960
• Other Study ID Numbers: 15D.468
• First Posted: Feb 15, 2017
• Last Update Posted: Dec 18, 2019
• Last Verified: Dec 1, 2019

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Squamous Cell Carcinoma of Head and Neck

Study Results

Participant Flow

Arm/Group Title	Diagnostic (Helical CT, PET/CT, MRI, CBCT)
Arm/Group Description	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. 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 Therapeutic Conventional Surgery: Undergo resection of tumor Histopathologic Examination: Correlative studies
Period Title: Overall Study
STARTED	8
COMPLETED	8
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	Diagnostic (Helical CT, PET/CT, MRI, CBCT)
Arm/Group Description	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. 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 Therapeutic Conventional Surgery: Undergo resection of tumor Histopathologic Examination: Correlative studies
Overall Participants	8
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	5 62.5%
>=65 years	3 37.5%
Sex: Female, Male (Count of Participants)
Female	3 37.5%
Male	5 62.5%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	0 0%
Not Hispanic or Latino	8 100%
Unknown or Not Reported	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	1 12.5%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	0 0%
White	7 87.5%
More than one race	0 0%
Unknown or Not Reported	0 0%
Region of Enrollment (participants) [Number]
United States	8 100%

Outcome Measures

1. Primary Outcome

Title	Accurate Predication of the Presence or Absence of Bone Invasion by Oral Squamous Cell Carcinoma by Helical CT, PET/CT, MRI and CBCT
Description	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
Time Frame	Up to 2 years

Outcome Measure Data

Analysis Population Description

The study was terminated by the IRB. Sincere efforts were made to gather and report the data, however, no data is available for the study.

Arm/Group Title	Diagnostic (Helical CT, PET/CT, MRI, CBCT)
Arm/Group Description	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. 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 Therapeutic Conventional Surgery: Undergo resection of tumor Histopathologic Examination: Correlative studies
Measure Participants	0

2. Secondary Outcome

Title	Incidence of Sparing Resection
Time Frame	Up to 2 years

Outcome Measure Data

Analysis Population Description

The study was terminated by the IRB. Sincere efforts were made to gather and report the data, however, no data is available for the study.

Arm/Group Title	Diagnostic (Helical CT, PET/CT, MRI, CBCT)
Arm/Group Description	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. 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 Therapeutic Conventional Surgery: Undergo resection of tumor Histopathologic Examination: Correlative studies
Measure Participants	0

Adverse Events

Time Frame	baseline to 30 days after completion of study treatment
Arm/Group Title	Diagnostic (Helical CT, PET/CT, MRI, CBCT)
Arm/Group Description	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. 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 Therapeutic Conventional Surgery: Undergo resection of tumor Histopathologic Examination: Correlative studies
All Cause Mortality
	Diagnostic (Helical CT, PET/CT, MRI, CBCT)
	Affected / at Risk (%)	# Events
Total	0/8 (0%)
Serious Adverse Events
	Diagnostic (Helical CT, PET/CT, MRI, CBCT)
	Affected / at Risk (%)	# Events
Total	0/8 (0%)
Other (Not Including Serious) Adverse Events
	Diagnostic (Helical CT, PET/CT, MRI, CBCT)
	Affected / at Risk (%)	# Events
Total	0/8 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.