Ignite Creation Date:
2025-12-24 @ 10:02 PM
Ignite Modification Date:
2026-02-24 @ 11:00 AM
Study NCT ID:
NCT02919332
Status:
WITHDRAWN
Last Update Posted:
2020-07-24
First Post:
2016-08-30
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Delayed 18F-FDG PET/CT in Improving Visualization of Brain Tumors in Patients With Glioblastoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005909', 'term': 'Glioblastoma'}, {'id': 'D005910', 'term': 'Glioma'}], 'ancestors': [{'id': 'D001254', 'term': 'Astrocytoma'}, {'id': 'D018302', 'term': 'Neoplasms, Neuroepithelial'}, {'id': 'D017599', 'term': 'Neuroectodermal Tumors'}, {'id': 'D009373', 'term': 'Neoplasms, Germ Cell and Embryonal'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009380', 'term': 'Neoplasms, Nerve Tissue'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019788', 'term': 'Fluorodeoxyglucose F18'}, {'id': 'D009682', 'term': 'Magnetic Resonance Spectroscopy'}], 'ancestors': [{'id': 'D003847', 'term': 'Deoxyglucose'}, {'id': 'D003837', 'term': 'Deoxy Sugars'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D013057', 'term': 'Spectrum Analysis'}, {'id': 'D002623', 'term': 'Chemistry Techniques, Analytical'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'No participants were enrolled', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2016-06-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-02', 'completionDateStruct': {'date': '2018-12-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-07-22', 'studyFirstSubmitDate': '2016-08-30', 'studyFirstSubmitQcDate': '2016-09-27', 'lastUpdatePostDateStruct': {'date': '2020-07-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-09-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-12-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Tumor-to-background ratio on delayed scans (240 min after injection)', 'timeFrame': 'Baseline up to 240 minutes after injection', 'description': 'Ratio between Standardized uptake values (tumor region) and Standardized uptake values (physiological uptake of brain tissue)'}, {'measure': 'Tumor-to-background ratio on standard scans (60 min after injection)', 'timeFrame': 'Baseline up to 60 minutes after injection', 'description': 'Ratio between Standardized uptake values (tumor region) and Standardized uptake values (physiological uptake of brain tissue)'}], 'secondaryOutcomes': [{'measure': 'Standard uptake value comparison', 'timeFrame': '240 minutes post injection', 'description': 'Comparison of Standardized uptake values (tumor region) to visual and quantitative parameters on delayed scans (240 min after injection)'}, {'measure': 'Standard uptake value comparison', 'timeFrame': '60 minutes post injection', 'description': 'Comparison of Standardized uptake values (tumor region) to visual and quantitative parameters on standard scans (60 min after injection)'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Glioblastoma', 'Glioma']}, 'descriptionModule': {'briefSummary': 'This clinical trial studies how well delayed fludeoxyglucose F-18 (18F-FDG) positron emission tomography (PET)/computed tomography (CT) works in improving visualization of brain tumors in patients with glioblastoma. Radiotracers such as 18F-FDG are highly taken up by tumors in the brain and are visualized using PET/CT. Increasing the interval of time between 18F-FDG administration and PET/CT scan may improve the visualization of brain tumors in patients with glioblastoma.', 'detailedDescription': 'PRIMARY OBJECTIVES:\n\nI. To improve the visualization/delineation of glioblastoma lesions using delayed 18F-FDG PET/CT imaging.\n\nOUTLINE:\n\nPatients receive fludeoxyglucose F-18 intravenously (IV). Patients then undergo a standard of care PET/CT scan at 60 minutes and a second PET/CT scan at 240 minutes after injection.\n\nNote:\n\nStandard Uptake Value (SUV) is defined for state-of-the art PET/CT scanners as Standardized uptake values = count activity per ml within region of interest (MBq/ml)/\\[injected dose (MBq)/body weight (kgx1000)\\]'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients older than 18 years of age who have been diagnosed with a brain tumor and are undergoing a PET/CT scan..', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with histologically proven high grade glioma scheduled for 18F-FDG PET/CT\n\nExclusion Criteria:\n\n* Severe psychiatric illness\n* Inability to give written consent\n* Breast feeding/pregnancy'}, 'identificationModule': {'nctId': 'NCT02919332', 'briefTitle': 'Delayed 18F-FDG PET/CT in Improving Visualization of Brain Tumors in Patients With Glioblastoma', 'organization': {'class': 'OTHER', 'fullName': 'Jonsson Comprehensive Cancer Center'}, 'officialTitle': 'Improved Visualization of Glioblastoma Using Delayed 18F-FDG PET/CT.', 'orgStudyIdInfo': {'id': '16-000600'}, 'secondaryIdInfos': [{'id': 'NCI-2016-01214', 'type': 'REGISTRY', 'domain': 'CTRP (Clinical Trial Reporting Program)'}, {'id': 'JCCCID655', 'type': 'OTHER', 'domain': 'UCLA / Jonsson Comprehensive Cancer Center'}, {'id': '16-000600', 'type': 'OTHER', 'domain': 'UCLA / Jonsson Comprehensive Cancer Center'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Diagnostic (18F-FDG PET/CT)', 'description': 'Patients receive fludeoxyglucose F-18 IV. Patients then undergo a standard of care PET/CT scan at 60 minutes and a second PET/CT scan at 240 minutes after injection.', 'interventionNames': ['Procedure: Computed Tomography', 'Radiation: Fludeoxyglucose F-18', 'Procedure: Positron Emission Tomography']}], 'interventions': [{'name': 'Computed Tomography', 'type': 'PROCEDURE', 'otherNames': ['CAT', 'CAT Scan', 'Computerized Axial Tomography', 'Computerized Tomography', 'CT', 'CT SCAN', 'tomography'], 'description': 'Undergo 18F-FDG PET/CT', 'armGroupLabels': ['Diagnostic (18F-FDG PET/CT)']}, {'name': 'Fludeoxyglucose F-18', 'type': 'RADIATION', 'otherNames': ['18FDG', 'FDG', 'fludeoxyglucose F 18', 'Fludeoxyglucose F18', 'Fluorine-18 2-Fluoro-2-deoxy-D-Glucose', 'Fluorodeoxyglucose F18'], 'description': 'Given IV', 'armGroupLabels': ['Diagnostic (18F-FDG PET/CT)']}, {'name': 'Positron Emission Tomography', 'type': 'PROCEDURE', 'otherNames': ['Medical Imaging, Positron Emission Tomography', 'PET', 'PET SCAN', 'Positron Emission Tomography Scan', 'Positron-Emission Tomography', 'proton magnetic resonance spectroscopic imaging'], 'description': 'Undergo 18F-FDG PET/CT', 'armGroupLabels': ['Diagnostic (18F-FDG PET/CT)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90095', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'UCLA / Jonsson Comprehensive Cancer Center', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}], 'overallOfficials': [{'name': 'Johannes Czernin', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UCLA / Jonsson Comprehensive Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jonsson Comprehensive Cancer Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}