Modern Hybrid Imaging in Patients With OSCC

NCT04280159 | Completed

• 1 other identifier: PETOSCC
• Study Type: observational
• Target: 265
• Locations: 1 country
• Sites: 1

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.

Conditions

Neoplasm

Keywords

Head and Neck; SCC; PET/CT; Staging

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (5)

• Diagnostic accuracy of MRI to detect the primary tumor

  2013-2018

• Diagnostic accuracy of MRI to detect lymph nodes metastases

  2013-2018

• Diagnostic accuracy of CT to detect the primary tumor

  2013-2018

• Diagnostic accuracy of CT to detect lymph nodes metastases

  2013-2018

• Diagnostic accuracy of CT to detect distant lymph node metastases.

  2013-2018

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patient with squamous cell carcinoma of the oral cavity,

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Wuerzburg University Hospital: lead

Study Sites (1)

Department of Cranio- and Maxillofacial Surgery

Würzburg, 97070, Germany

Location

MeSH Terms

Conditions

Neoplasms

Study Officials

• Urs Müller-Richter, MD, DDS, PhD

  Dpt. of CMF, University Hospital Wuerzburg

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 4, 2020
• First Posted: February 21, 2020
• Study Start: June 28, 2013
• Primary Completion: December 31, 2018
• Study Completion: December 31, 2018
• Last Updated: February 21, 2020

Record last verified: 2020-02

Locations

DE (1)