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Modern Hybrid Imaging in Patients With OSCC (PETOSCC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04280159
Recruitment Status : Completed
First Posted : February 21, 2020
Last Update Posted : February 21, 2020
Sponsor:
Information provided by (Responsible Party):
Wuerzburg University Hospital

Brief 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.

Condition or disease
Neoplasm

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Study Type : Observational
Actual Enrollment : 265 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Modern Hybrid Imaging for Staging and Monitoring Patients With Oral Squamous Cell Carcinoma
Actual Study Start Date : June 28, 2013
Actual Primary Completion Date : December 31, 2018
Actual Study Completion Date : December 31, 2018

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Diagnostic accuracy of FGD-PET/CT to detect the primary tumor [ Time Frame: 2013-2018 ]
    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.

  2. Diagnostic accuracy of FGD-PET/CT to detect lymph nodes metastases [ Time Frame: 2013-2018 ]
    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.

  3. Diagnostic accuracy of FGD-PET/CT to detect distant lymph node metastases. [ Time Frame: 2013-2018 ]
    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.


Secondary Outcome Measures :
  1. Diagnostic accuracy of MRI to detect the primary tumor [ Time Frame: 2013-2018 ]
    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.

  2. Diagnostic accuracy of MRI to detect lymph nodes metastases [ Time Frame: 2013-2018 ]
    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.

  3. Diagnostic accuracy of CT to detect the primary tumor [ Time Frame: 2013-2018 ]
    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.

  4. Diagnostic accuracy of CT to detect lymph nodes metastases [ Time Frame: 2013-2018 ]
    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.

  5. Diagnostic accuracy of CT to detect distant lymph node metastases. [ Time Frame: 2013-2018 ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patient with squamous cell carcinoma of the oral cavity,
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04280159


Locations
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Germany
Department of Cranio- and Maxillofacial Surgery
Würzburg, Germany, 97070
Sponsors and Collaborators
Wuerzburg University Hospital
Investigators
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Principal Investigator: Urs Müller-Richter, MD, DDS, PhD Dpt. of CMF, University Hospital Wuerzburg
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Responsible Party: Wuerzburg University Hospital
ClinicalTrials.gov Identifier: NCT04280159    
Other Study ID Numbers: PETOSCC
First Posted: February 21, 2020    Key Record Dates
Last Update Posted: February 21, 2020
Last Verified: February 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Wuerzburg University Hospital:
Head and Neck
SCC
PET/CT
Staging