Ignite Creation Date:
2025-12-24 @ 6:44 PM
Ignite Modification Date:
2025-12-29 @ 11:22 PM
Study NCT ID:
NCT02902757
Status:
COMPLETED
Last Update Posted:
2025-12-17
First Post:
2016-09-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
FDG PET/CT in Monitoring Very Early Therapy Response in Patients With Glioblastoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005909', 'term': 'Glioblastoma'}], 'ancestors': [{'id': 'D001254', 'term': 'Astrocytoma'}, {'id': 'D005910', 'term': 'Glioma'}, {'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': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 7}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-08-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2025-01-29', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-12-15', 'studyFirstSubmitDate': '2016-09-12', 'studyFirstSubmitQcDate': '2016-09-12', 'lastUpdatePostDateStruct': {'date': '2025-12-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-09-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2025-01-29', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes in glucose uptake', 'timeFrame': 'From baseline up to 48 hours', 'description': 'Standardized uptake values (SUV) will be calculated for different organs and for regions of tumor. Further, regional target to background count-activity ratios will be established.'}, {'measure': 'Very early changes in tumor glucose uptake predictive for objective treatments response and survival assessed using RANO criteria', 'timeFrame': 'One PET/CT 48 hours after start of therapy', 'description': 'SUV will be calculated for different organs and for regions of tumor. Further, regional target to background count-activity ratios will be established.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['FDG', 'PET/CT very early response (48 hrs)'], 'conditions': ['Glioblastoma']}, 'descriptionModule': {'briefSummary': "This pilot clinical trial studies fluordeoxyglucose (fludeoxyglucose) F-18 (FDG) positron emission tomography (PET)/computed tomography (CT) in monitoring very early therapy response in patients with glioblastoma. Diagnostic procedures, such as FDG PET/CT, may help measure a patient's response to earlier treatment. Chemotherapy can induce very rapid changes to the tumor's glucose consumption which can be measured with imaging. FDG PET/CT shortly after the start of therapy may help identify very early therapy response in patients with glioblastoma.", 'detailedDescription': 'PRIMARY OBJECTIVES:\n\nI. To assess very early response to therapy in glioblastoma patients using 18F-FDG PET/CT.\n\nII. Evaluate very early changes in FDG uptake within 48 hours of start of therapy and correlate them with objective response parameters such as Response Assessment in Neuro-Oncology (RANO) and survival.\n\nOUTLINE:\n\nPatients undergo standard FDG PET/CT scan 6-8 weeks before start of chemotherapy and one additional FDG PET/CT scan within 48 hours of the start of chemotherapy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with histologically proven high grade glioma\n* Intention to start therapy\n\nExclusion Criteria:\n\n* Severe psychiatric illness\n* Inability to give written consent\n* Breast feeding / pregnancy'}, 'identificationModule': {'nctId': 'NCT02902757', 'briefTitle': 'FDG PET/CT in Monitoring Very Early Therapy Response in Patients With Glioblastoma', 'organization': {'class': 'OTHER', 'fullName': 'Jonsson Comprehensive Cancer Center'}, 'officialTitle': 'Very Early Response Monitoring in Patients With Glioblastoma Undergoing Therapy Using FDG PET/CT', 'orgStudyIdInfo': {'id': '15-000409'}, 'secondaryIdInfos': [{'id': 'NCI-2016-00583', 'type': 'REGISTRY', 'domain': 'CTRP (Clinical Trial Reporting Program)'}, {'id': '15-000409', 'type': 'OTHER', 'domain': 'UCLA / Jonsson Comprehensive Cancer Center'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment (FDG PET/CT)', 'description': 'Patients undergo standard FDG PET/CT scan 6-8 weeks before start of chemotherapy and one additional FDG PET/CT scan within 48 hours of the start of chemotherapy.', '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 FDG PET/CT', 'armGroupLabels': ['Treatment (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': 'Undergo FDG PET/CT', 'armGroupLabels': ['Treatment (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 FDG PET/CT', 'armGroupLabels': ['Treatment (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, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UCLA / Jonsson Comprehensive Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jonsson Comprehensive Cancer Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}, {'name': 'National Institutes of Health (NIH)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}