Modern Hybrid Imaging in Patients With OSCC (PETOSCC)

Modern Hybrid Imaging for Staging and Monitoring Patients With Oral Squamous Cell Carcinoma

Prospective diagnostic study to determine the diagnostic accuracy of preoperative 18F--fluorodeoxyglucose (FDG) positron emission tomography/computed tomography (PET/CT) in detecting local tumor extent, cervical lymph node metastases and distant metastases/secondary primary tumor.

Study Overview

• Status: Completed
• Conditions: Neoplasm

• Study Type: Observational
• Enrollment (Actual): 265

Contacts and Locations

Study Locations

• Germany
  • Würzburg, Germany, 97070
    • Department of Cranio- and Maxillofacial Surgery

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patient with squamous cell carcinoma of the oral cavity,

Description

Inclusion Criteria:

• Histopathological proven head and neck carcinoma
• Written inform consent
• 18 years of age

Exclusion Criteria:

• Cancer of unknown primary
• En-bloc resection of lymph node levels
• Uncertainties regarding the removed lymph node levels

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Diagnostic accuracy of FGD-PET/CT to detect the primary tumor	Visual assessment of FDG-PET/CT will be performed according to current guidelines. The localization, expansion, and infiltration of osseous structures will be recorded. The outcome measure is the correct diagnosis (1 = correct; 0 = false) with regards to the histopathological analysis. The outcome measure will then be used to calculate the diagnostic accuracy of FDG-PET/CT to detect the primary tumor.	2013-2018
Diagnostic accuracy of FGD-PET/CT to detect lymph nodes metastases	Visual assessment of FDG-PET/CT will be performed according to current guidelines. The presence and number of nodal metastasis will be recorded for each cervical lymph node level. The outcome measure is the correct diagnosis (1 = correct; 0 = false) with regards to the histopathological analysis. The analysis will be performed on a patient level (lymph node metastasis yes/no), on the nodal metastatic involvement of cervical sides and lymph node levels. The outcome measure will then be used to calculate the diagnostic accuracy of FDG-PET/CT to detect lymph node metastases.	2013-2018
Diagnostic accuracy of FGD-PET/CT to detect distant lymph node metastases.	Visual assessment of FDG-PET/CT will be performed according to current guidelines. The presence, localization and number of distant nodal metastasis will be recorded. The outcome measure is the correct diagnosis (1 = correct; 0 = false) with regards to the histopathological analysis. The outcome measure will then be used to calculate the diagnostic accuracy of FDG-PET/CT to detect lymph node metastases.	2013-2018

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Diagnostic accuracy of MRI to detect the primary tumor	Visual assessment of MRI will be performed according to current guidelines. The localization, expansion, and infiltration of osseous structures will be recorded. The outcome measure is the correct diagnosis (1 = correct; 0 = false) with regards to the histopathological analysis. The outcome measure will then be used to calculate the diagnostic accuracy of MRI to detect the primary tumor.	2013-2018
Diagnostic accuracy of MRI to detect lymph nodes metastases	Visual assessment of MRI will be performed according to current guidelines. The presence and number of nodal metastasis will be recorded for each cervical lymph node level. The outcome measure is the correct diagnosis (1 = correct; 0 = false) with regards to the histopathological analysis. The analysis will be performed on a patient level (lymph node metastasis yes/no), on the nodal metastatic involvement of cervical sides and lymph node levels. The outcome measure will then be used to calculate the diagnostic accuracy of MRI to detect lymph node metastases.	2013-2018
Diagnostic accuracy of CT to detect the primary tumor	Visual assessment of CT will be performed according to current guidelines. The localization, expansion, and infiltration of osseous structures will be recorded. The outcome measure is the correct diagnosis (1 = correct; 0 = false) with regards to the histopathological analysis. The outcome measure will then be used to calculate the diagnostic accuracy of CT to detect the primary tumor.	2013-2018
Diagnostic accuracy of CT to detect lymph nodes metastases	Visual assessment of CT will be performed according to current guidelines. The presence and number of nodal metastasis will be recorded for each cervical lymph node level. The outcome measure is the correct diagnosis (1 = correct; 0 = false) with regards to the histopathological analysis. The analysis will be performed on a patient level (lymph node metastasis yes/no), on the nodal metastatic involvement of cervical sides and lymph node levels. The outcome measure will then be used to calculate the diagnostic accuracy of CT to detect lymph node metastases.	2013-2018
Diagnostic accuracy of CT to detect distant lymph node metastases.	Visual assessment of CT will be performed according to current guidelines. The presence, localization and number of distant nodal metastasis will be recorded. The outcome measure is the correct diagnosis (1 = correct; 0 = false) with regards to the histopathological analysis. The outcome measure will then be used to calculate the diagnostic accuracy of CT to detect lymph node metastases.	2013-2018

Collaborators and Investigators

• Sponsor: Wuerzburg University Hospital
• Investigators: Principal Investigator: Urs Müller-Richter, MD, DDS, PhD, Dpt. of CMF, University Hospital Wuerzburg

Study record dates

Study Major Dates

• Study Start (Actual): June 28, 2013
• Primary Completion (Actual): December 31, 2018
• Study Completion (Actual): December 31, 2018

Study Registration Dates

• First Submitted: February 4, 2020
• First Submitted That Met QC Criteria: February 19, 2020
• First Posted (Actual): February 21, 2020

Study Record Updates

• Last Update Posted (Actual): February 21, 2020
• Last Update Submitted That Met QC Criteria: February 19, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Keywords: PET/CT; Head and Neck; SCC; Staging
• Other Study ID Numbers: PETOSCC

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No