Modern Hybrid Imaging in Patients With OSCC

Neoplasm Clinical Trial

— PETOSCC  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04280159
• Other study ID #: PETOSCC
• Status: Completed
• Start date: June 28, 2013
• Est. completion date: December 31, 2018

Study information

• Verified date: February 2020
• Source: Wuerzburg University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 265
• Est. completion date: December 31, 2018
• Est. primary completion date: December 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Neoplasm

Locations

Country	Name	City	State
Germany	Department of Cranio- and Maxillofacial Surgery	Würzburg

Sponsors (1)

Lead Sponsor	Collaborator
Wuerzburg University Hospital

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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