NCT03053960|TerminatedResultsDMC

Study Stopped

Terminated by IRB

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

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

Sidney Kimmel Cancer Center at Thomas Jefferson University ClinicalTrials.gov

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2 other identifiers

15D.468JT 6307

Study Type

observational

Target

Locations

0 countries

Sites

N/A

Timeline

RegisteredFeb 2017

StartedNov 2015

CompletionNov 2018

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.

Trial Health

Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at below P25 for all trials

Timeline

Completed

Started Nov 2015

Typical duration for all trials

Status

terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

2.9 years study duration

Study Start

First participant enrolled

November 24, 2015

Completed

1.2 years until next milestone

First Submitted

Initial submission to the registry

January 31, 2017

Completed

15 days until next milestone

First Posted

Study publicly available on registry

February 15, 2017

Completed

1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2018

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2018

Completed

1.1 years until next milestone

Results Posted

Study results publicly available

December 18, 2019

Completed

Last Updated

April 30, 2025

Status Verified

April 1, 2025

Enrollment Period

2.9 years

First QC Date

January 31, 2017

Results QC Date

October 29, 2019

Last Update Submit

April 28, 2025

Conditions

Oral Cavity Squamous Cell Carcinoma

Outcome Measures

Primary Outcomes (1)

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 Outcomes (1)

Incidence of Sparing Resection
Up to 2 years

Study Arms (1)

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 TomographyDevice: Positron Emission Tomography and Computed Tomography ScanDevice: Cone-Beam Computed TomographyDevice: Magnetic Resonance ImagingProcedure: Therapeutic Conventional SurgeryProcedure: Histopathologic Examination