Ignite Creation Date:
2025-12-25 @ 2:09 AM
Ignite Modification Date:
2026-03-14 @ 5:32 AM
Study NCT ID:
NCT03053960
Status:
TERMINATED
Last Update Posted:
2025-04-30
First Post:
2017-01-31
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Helical CT, PET/CT, MRI, and CBCT Alone or in Combination in Predicting Jaw Invasion in Patients With Oral Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000077195', 'term': 'Squamous Cell Carcinoma of Head and Neck'}], 'ancestors': [{'id': 'D002294', 'term': 'Carcinoma, Squamous Cell'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006258', 'term': 'Head and Neck Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014057', 'term': 'Tomography, X-Ray Computed'}, {'id': 'D000072078', 'term': 'Positron Emission Tomography Computed Tomography'}, {'id': 'D054893', 'term': 'Cone-Beam Computed Tomography'}, {'id': 'D008279', 'term': 'Magnetic Resonance Imaging'}], 'ancestors': [{'id': 'D007090', 'term': 'Image Interpretation, Computer-Assisted'}, {'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D011856', 'term': 'Radiographic Image Enhancement'}, {'id': 'D007089', 'term': 'Image Enhancement'}, {'id': 'D010781', 'term': 'Photography'}, {'id': 'D011859', 'term': 'Radiography'}, {'id': 'D014056', 'term': 'Tomography, X-Ray'}, {'id': 'D014054', 'term': 'Tomography'}, {'id': 'D049268', 'term': 'Positron-Emission Tomography'}, {'id': 'D014055', 'term': 'Tomography, Emission-Computed'}, {'id': 'D064847', 'term': 'Multimodal Imaging'}, {'id': 'D011877', 'term': 'Radionuclide Imaging'}, {'id': 'D003947', 'term': 'Diagnostic Techniques, Radioisotope'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Lionel.Gold@jefferson.edu', 'phone': '215-955-6215', 'title': 'Dr. Lionel Gold', 'organization': 'Sidney Kimmel Cancer Center at Thomas Jefferson University'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'baseline to 30 days after completion of study treatment', 'eventGroups': [{'id': 'EG000', 'title': 'Diagnostic (Helical CT, PET/CT, MRI, CBCT)', 'description': 'Patients undergo helical (Computed Tomography) CT,(Positron Emission Tomography and Computed Tomography) PET/CT, (Magnetic Resonance Imaging) MRI, and (Cone-Beam Computed Tomography) CBCT scans. Patients also undergo therapeutic conventional surgical resection of tumor.\n\nComputed Tomography: Undergo helical CT scan\n\nPositron Emission Tomography and Computed Tomography Scan: Undergo PET/CT scan\n\nCone-Beam Computed Tomography: Undergo CBCT scan\n\nMagnetic Resonance Imaging: Undergo MRI scan\n\nTherapeutic Conventional Surgery: Undergo resection of tumor\n\nHistopathologic Examination: Correlative studies', 'otherNumAtRisk': 8, 'deathsNumAtRisk': 8, 'otherNumAffected': 0, 'seriousNumAtRisk': 8, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Accurate Predication of the Presence or Absence of Bone Invasion by Oral Squamous Cell Carcinoma by Helical CT, PET/CT, MRI and CBCT', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Diagnostic (Helical CT, PET/CT, MRI, CBCT)', 'description': 'Patients undergo helical (Computed Tomography) CT,(Positron Emission Tomography and Computed Tomography) PET/CT, (Magnetic Resonance Imaging) MRI, and (Cone-Beam Computed Tomography) CBCT scans. Patients also undergo therapeutic conventional surgical resection of tumor.\n\nComputed Tomography: Undergo helical CT scan\n\nPositron Emission Tomography and Computed Tomography Scan: Undergo PET/CT scan\n\nCone-Beam Computed Tomography: Undergo CBCT scan\n\nMagnetic Resonance Imaging: Undergo MRI scan\n\nTherapeutic Conventional Surgery: Undergo resection of tumor\n\nHistopathologic Examination: Correlative studies'}], 'timeFrame': 'Up to 2 years', 'description': 'Sensitivity and specificity of the clinical exam, CBCT, helical CT, PET/CT, MRI and any other imaging modality used in detection of bone invasion will be calculated, as compared to the histological examination of the specimens. The positive and negative predictive value will be calculated for each modality using the true positive and negatives as well as false positive and negative values', 'reportingStatus': 'POSTED', 'populationDescription': 'The study was terminated by the IRB. Sincere efforts were made to gather and report the data, however, no data is available for the study.'}, {'type': 'SECONDARY', 'title': 'Incidence of Sparing Resection', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Diagnostic (Helical CT, PET/CT, MRI, CBCT)', 'description': 'Patients undergo helical (Computed Tomography) CT,(Positron Emission Tomography and Computed Tomography) PET/CT, (Magnetic Resonance Imaging) MRI, and (Cone-Beam Computed Tomography) CBCT scans. Patients also undergo therapeutic conventional surgical resection of tumor.\n\nComputed Tomography: Undergo helical CT scan\n\nPositron Emission Tomography and Computed Tomography Scan: Undergo PET/CT scan\n\nCone-Beam Computed Tomography: Undergo CBCT scan\n\nMagnetic Resonance Imaging: Undergo MRI scan\n\nTherapeutic Conventional Surgery: Undergo resection of tumor\n\nHistopathologic Examination: Correlative studies'}], 'timeFrame': 'Up to 2 years', 'reportingStatus': 'POSTED', 'populationDescription': 'The study was terminated by the IRB. Sincere efforts were made to gather and report the data, however, no data is available for the study.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Diagnostic (Helical CT, PET/CT, MRI, CBCT)', 'description': 'Patients undergo helical (Computed Tomography) CT,(Positron Emission Tomography and Computed Tomography) PET/CT, (Magnetic Resonance Imaging) MRI, and (Cone-Beam Computed Tomography) CBCT scans. Patients also undergo therapeutic conventional surgical resection of tumor.\n\nComputed Tomography: Undergo helical CT scan\n\nPositron Emission Tomography and Computed Tomography Scan: Undergo PET/CT scan\n\nCone-Beam Computed Tomography: Undergo CBCT scan\n\nMagnetic Resonance Imaging: Undergo MRI scan\n\nTherapeutic Conventional Surgery: Undergo resection of tumor\n\nHistopathologic Examination: Correlative studies'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Diagnostic (Helical CT, PET/CT, MRI, CBCT)', 'description': 'Patients undergo helical (Computed Tomography) CT,(Positron Emission Tomography and Computed Tomography) PET/CT, (Magnetic Resonance Imaging) MRI, and (Cone-Beam Computed Tomography) CBCT scans. Patients also undergo therapeutic conventional surgical resection of tumor.\n\nComputed Tomography: Undergo helical CT scan\n\nPositron Emission Tomography and Computed Tomography Scan: Undergo PET/CT scan\n\nCone-Beam Computed Tomography: Undergo CBCT scan\n\nMagnetic Resonance Imaging: Undergo MRI scan\n\nTherapeutic Conventional Surgery: Undergo resection of tumor\n\nHistopathologic Examination: Correlative studies'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '5', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '5', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '8', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '7', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2016-03-23', 'size': 623102, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2019-11-21T12:53', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 8}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'Terminated by IRB', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2015-11-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2018-11-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-04-28', 'studyFirstSubmitDate': '2017-01-31', 'resultsFirstSubmitDate': '2019-10-29', 'studyFirstSubmitQcDate': '2017-02-10', 'lastUpdatePostDateStruct': {'date': '2025-04-30', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-12-17', 'studyFirstPostDateStruct': {'date': '2017-02-15', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2019-12-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-11-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Accurate Predication of the Presence or Absence of Bone Invasion by Oral Squamous Cell Carcinoma by Helical CT, PET/CT, MRI and CBCT', 'timeFrame': 'Up to 2 years', 'description': 'Sensitivity and specificity of the clinical exam, CBCT, helical CT, PET/CT, MRI and any other imaging modality used in detection of bone invasion will be calculated, as compared to the histological examination of the specimens. The positive and negative predictive value will be calculated for each modality using the true positive and negatives as well as false positive and negative values'}], 'secondaryOutcomes': [{'measure': 'Incidence of Sparing Resection', 'timeFrame': 'Up to 2 years'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Oral Cavity Squamous Cell Carcinoma']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.kimmelcancercenter.org', 'label': 'Sidney Kimmel Cancer Center'}, {'url': 'http://hospitals.jefferson.edu/', 'label': 'Thomas Jefferson University Hospital'}]}, 'descriptionModule': {'briefSummary': 'This clinical trial studies how well helical computed tomography (CT), positron emission tomography (PET)/CT, magnetic resonance imaging (MRI), and cone beam computed tomography (CBCT) work alone or in combination in predicting whether tumor cells have spread to the jaw bone (jaw invasion) in patients with oral cancer. Imaging, such as helical CT, PET/CT, MRI, and CBCT, may help find out how far cancer has spread. Accurate prediction of the presence or absence of jaw invasion may help create a better surgical treatment plan for patients with oral cancer.', 'detailedDescription': 'PRIMARY OBJECTIVES:\n\nI. To determine which imaging modality or combination of imaging methods, in conjunction with clinical and histological examination, will most accurately predict the presence or absence of invasion of the mandible or maxilla by intraoral squamous cell carcinoma (SCC).\n\nSECONDARY OBJECTIVES:\n\nI. To compare the histopathologic findings to the radiologic findings.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The data from all of the subjects that are enrolled and have consented to be a part of the study will be analyzed', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of squamous cell carcinoma of the oral cavity\n* Able to read and sign and informed consent\n\nExclusion Criteria:\n\n* Prior mandibular surgery\n* Primary intraosseous carcinoma\n* Prior history of radiation to the mandible\n* Obvious finding of clinical invasion of the mandible'}, 'identificationModule': {'nctId': 'NCT03053960', 'briefTitle': 'Helical CT, PET/CT, MRI, and CBCT Alone or in Combination in Predicting Jaw Invasion in Patients With Oral Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Thomas Jefferson University'}, 'officialTitle': 'Predictability of Carcinomatous Invasion of the Maxilla or Mandible: An Assessment of Radiologic Modalities With Histologic Correlation', 'orgStudyIdInfo': {'id': '15D.468'}, 'secondaryIdInfos': [{'id': 'JT 6307', 'type': 'OTHER', 'domain': 'JeffTrial Number'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Diagnostic (helical CT, PET/CT, MRI, CBCT)', 'description': 'Patients undergo helical (Computed Tomography) CT,(Positron Emission Tomography and Computed Tomography) PET/CT, (Magnetic Resonance Imaging) MRI, and (Cone-Beam Computed Tomography) CBCT scans. Patients also undergo therapeutic conventional surgical resection of tumor.', 'interventionNames': ['Device: Computed Tomography', 'Device: Positron Emission Tomography and Computed Tomography Scan', 'Device: Cone-Beam Computed Tomography', 'Device: Magnetic Resonance Imaging', 'Procedure: Therapeutic Conventional Surgery', 'Procedure: Histopathologic Examination']}], 'interventions': [{'name': 'Computed Tomography', 'type': 'DEVICE', 'otherNames': ['CAT Scan', 'Computerized Axial Tomography', 'CAT'], 'description': 'Undergo helical CT scan', 'armGroupLabels': ['Diagnostic (helical CT, PET/CT, MRI, CBCT)']}, {'name': 'Positron Emission Tomography and Computed Tomography Scan', 'type': 'DEVICE', 'otherNames': ['PET-CT Scan', 'PET/CT SCAN'], 'description': 'Undergo PET/CT scan', 'armGroupLabels': ['Diagnostic (helical CT, PET/CT, MRI, CBCT)']}, {'name': 'Cone-Beam Computed Tomography', 'type': 'DEVICE', 'description': 'Undergo CBCT scan', 'armGroupLabels': ['Diagnostic (helical CT, PET/CT, MRI, CBCT)']}, {'name': 'Magnetic Resonance Imaging', 'type': 'DEVICE', 'otherNames': ['MRI', 'MRI Scan'], 'description': 'Undergo MRI scan', 'armGroupLabels': ['Diagnostic (helical CT, PET/CT, MRI, CBCT)']}, {'name': 'Therapeutic Conventional Surgery', 'type': 'PROCEDURE', 'description': 'Undergo resection of tumor', 'armGroupLabels': ['Diagnostic (helical CT, PET/CT, MRI, CBCT)']}, {'name': 'Histopathologic Examination', 'type': 'PROCEDURE', 'otherNames': ['Histopathologic Study'], 'description': 'Correlative studies', 'armGroupLabels': ['Diagnostic (helical CT, PET/CT, MRI, CBCT)']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Lionel Gold, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Sidney Kimmel Cancer Center at Thomas Jefferson University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sidney Kimmel Cancer Center at Thomas Jefferson University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}