Ignite Creation Date:
2025-12-24 @ 12:05 PM
Ignite Modification Date:
2026-01-08 @ 7:22 AM
Study NCT ID:
NCT01240161
Status:
COMPLETED
Last Update Posted:
2017-08-29
First Post:
2010-11-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Personalized Translational Platform for Biomarker Discovery in Brain Tumors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005910', 'term': 'Glioma'}, {'id': 'D005909', 'term': 'Glioblastoma'}], 'ancestors': [{'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'}, {'id': 'D001254', 'term': 'Astrocytoma'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 37}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-08', 'completionDateStruct': {'date': '2016-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-08-28', 'studyFirstSubmitDate': '2010-11-10', 'studyFirstSubmitQcDate': '2010-11-10', 'lastUpdatePostDateStruct': {'date': '2017-08-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2010-11-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall Survival', 'timeFrame': '7 months'}, {'measure': 'Progression free Survival', 'timeFrame': '7 months', 'description': 'MRI and clinical criteria'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Glioblastoma multiforme', 'FLT', 'PET'], 'conditions': ['High Grade Glioma']}, 'descriptionModule': {'briefSummary': 'The central hypothesis for this proposal is that multimodal (clinical, imaging, tissue) biomarkers will better predict early brain tumor response to treatments and will be more reliable prognostic markers in patients with malignant brain tumors.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients presenting to BWH/DFCI emergency department (ED), inpatient, or neurology/ neurosurgery/ radiation oncology clinics with newly diagnosed brain masses (suspected high grade gliomas) will be consented and enrolled in this study after adequate explanation of the risks and benefits of the study.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Newly diagnosed or suspected high grade glioma ≥ 1cm in diameter on postoperative anatomic imaging (contrast MRI), prior to initiation of chemoXRT\n* Anticipated survival ≥6 months\n* Able to give informed consent\n* Capable of undergoing MRI and PET scans without the need for sedation or general anesthesia\n* Male or Female\n\nExclusion Criteria:\n\n* Prior radiation therapy and chemotherapy to the brain\n* Active intracranial infection or nonglial brain mass.\n* Recent large intracranial hemorrhage (\\<1 month)\n* Expected survival \\<6 months\n* Pregnant or nursing\n* Renal failure\n* Lives far from BWH and/or is unwilling/ unable to return for scheduled imaging visits.'}, 'identificationModule': {'nctId': 'NCT01240161', 'briefTitle': 'Personalized Translational Platform for Biomarker Discovery in Brain Tumors', 'organization': {'class': 'OTHER', 'fullName': "Brigham and Women's Hospital"}, 'officialTitle': 'Personalized Translational Platform for Biomarker Discovery in Brain Tumors', 'orgStudyIdInfo': {'id': '2008P000554'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients with high grade gliomas', 'description': 'All subjects will have radiographically suspected or surgically proven de novo high grade gliomas. There are no control patients.', 'interventionNames': ["Drug: FLT-PET/CT: (3'deoxy-3'-[(18)F] fluorothymidine) PET/CT"]}], 'interventions': [{'name': "FLT-PET/CT: (3'deoxy-3'-[(18)F] fluorothymidine) PET/CT", 'type': 'DRUG', 'description': 'Each patient will have 0-3 or more FLT-PET brain scans.', 'armGroupLabels': ['Patients with high grade gliomas']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92093', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'University of California at San Diego', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': "Brigham and Women's Hospital", 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'overallOfficials': [{'name': 'Marie Kijewski, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Brigham and Women's Hospital"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Marcelo F. Di Carli, MD, FACC', 'class': 'OTHER'}, 'collaborators': [{'name': 'Society of Nuclear Medicine and Molecular Imaging', 'class': 'UNKNOWN'}, {'name': 'General Electric', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Chief of Nuclear Medicine/PET', 'investigatorFullName': 'Marcelo F. Di Carli, MD, FACC', 'investigatorAffiliation': "Brigham and Women's Hospital"}}}}