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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04280159
Other study ID # PETOSCC
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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