Ignite Creation Date:
2025-12-24 @ 3:00 PM
Ignite Modification Date:
2025-12-24 @ 3:00 PM
Study NCT ID:
NCT04280159
Status:
COMPLETED
Last Update Posted:
2020-02-21
First Post:
2020-02-04
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Modern Hybrid Imaging in Patients With OSCC
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 265}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-06-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-02', 'completionDateStruct': {'date': '2018-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-02-19', 'studyFirstSubmitDate': '2020-02-04', 'studyFirstSubmitQcDate': '2020-02-19', 'lastUpdatePostDateStruct': {'date': '2020-02-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-02-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Diagnostic accuracy of FGD-PET/CT to detect the primary tumor', 'timeFrame': '2013-2018', 'description': '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.'}, {'measure': 'Diagnostic accuracy of FGD-PET/CT to detect lymph nodes metastases', 'timeFrame': '2013-2018', 'description': '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.'}, {'measure': 'Diagnostic accuracy of FGD-PET/CT to detect distant lymph node metastases.', 'timeFrame': '2013-2018', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Diagnostic accuracy of MRI to detect the primary tumor', 'timeFrame': '2013-2018', 'description': '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.'}, {'measure': 'Diagnostic accuracy of MRI to detect lymph nodes metastases', 'timeFrame': '2013-2018', 'description': '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.'}, {'measure': 'Diagnostic accuracy of CT to detect the primary tumor', 'timeFrame': '2013-2018', 'description': '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.'}, {'measure': 'Diagnostic accuracy of CT to detect lymph nodes metastases', 'timeFrame': '2013-2018', 'description': '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.'}, {'measure': 'Diagnostic accuracy of CT to detect distant lymph node metastases.', 'timeFrame': '2013-2018', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Head and Neck', 'SCC', 'PET/CT', 'Staging'], 'conditions': ['Neoplasm']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patient with squamous cell carcinoma of the oral cavity,', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Histopathological proven head and neck carcinoma\n* Written inform consent\n* 18 years of age\n\nExclusion Criteria:\n\n* Cancer of unknown primary\n* En-bloc resection of lymph node levels\n* Uncertainties regarding the removed lymph node levels'}, 'identificationModule': {'nctId': 'NCT04280159', 'acronym': 'PETOSCC', 'briefTitle': 'Modern Hybrid Imaging in Patients With OSCC', 'organization': {'class': 'OTHER', 'fullName': 'Wuerzburg University Hospital'}, 'officialTitle': 'Modern Hybrid Imaging for Staging and Monitoring Patients With Oral Squamous Cell Carcinoma', 'orgStudyIdInfo': {'id': 'PETOSCC'}}, 'contactsLocationsModule': {'locations': [{'zip': '97070', 'city': 'Würzburg', 'country': 'Germany', 'facility': 'Department of Cranio- and Maxillofacial Surgery', 'geoPoint': {'lat': 49.79391, 'lon': 9.95121}}], 'overallOfficials': [{'name': 'Urs Müller-Richter, MD, DDS, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Dpt. of CMF, University Hospital Wuerzburg'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Wuerzburg University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}