PETOSCC: Modern Hybrid Imaging in Patients With OSCC

• Sponsor: Wuerzburg University Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT04280159
• Collaborator: (none)
• Enrollment: 265
• Location: 1
• Actual Duration (Months): 66.1
• Patients Per Site Per Month: 4

Study Details

Study Description

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	Intervention/Treatment	Phase
Neoplasm

Study Design

• 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: Jun 28, 2013
• Actual Primary Completion Date: Dec 31, 2018
• Actual Study Completion Date: Dec 31, 2018

Outcome Measures

Primary Outcome Measures

1. Diagnostic accuracy of FGD-PET/CT to detect the primary tumor [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 [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. [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 [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 [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 [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 [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. [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Cranio- and Maxillofacial Surgery	Würzburg		Germany	97070

Sponsors and Collaborators

• Wuerzburg University Hospital

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Wuerzburg University Hospital
• ClinicalTrials.gov Identifier: NCT04280159
• Other Study ID Numbers: PETOSCC
• First Posted: Feb 21, 2020
• Last Update Posted: Feb 21, 2020
• Last Verified: Feb 1, 2020

• 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

Study Results

No Results Posted as of Feb 21, 2020