Ignite Creation Date:
2025-12-24 @ 6:33 PM
Ignite Modification Date:
2026-01-04 @ 9:09 AM
Study NCT ID:
NCT04846257
Status:
COMPLETED
Last Update Posted:
2021-04-19
First Post:
2021-04-12
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Specific Preoperative Dynamic Contrast-enhanced MRI Semi-quantitative Markers Can Correlate With Vascularity in Specific Areas of the Glioblastoma Tissue and Predict Recurrence
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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 260}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-04', 'completionDateStruct': {'date': '2021-02-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-04-14', 'studyFirstSubmitDate': '2021-04-12', 'studyFirstSubmitQcDate': '2021-04-14', 'lastUpdatePostDateStruct': {'date': '2021-04-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-04-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-01-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Recurrence of tumor', 'timeFrame': '2018-2021'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Glioblastoma']}, 'descriptionModule': {'briefSummary': 'Radiological Markers of vascularity as wash-in rate, washout rate, and capillary time to peak in different single tumour regions were extracted for all glioblastoma patients before being surgically resected from preoperative DCE-MRI. Tissue samples were obtained from different intratumoral regions and peritumoral oedema and evaluated for the vascular endothelial growth factor (VEGF)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with newly diagnosed glioblastoma', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with newly diagnosed glioblastoma with a maximum diameter from 3-5 cm as a single lesion identified by MRI.\n* The lesions should be surgically resected at the time of the presentation.\n\nExclusion Criteria: N/A'}, 'identificationModule': {'nctId': 'NCT04846257', 'briefTitle': 'Specific Preoperative Dynamic Contrast-enhanced MRI Semi-quantitative Markers Can Correlate With Vascularity in Specific Areas of the Glioblastoma Tissue and Predict Recurrence', 'organization': {'class': 'OTHER', 'fullName': 'Egyptian Medical Syndicate'}, 'officialTitle': 'Specific Preoperative Dynamic Contrast-enhanced MRI Semi-quantitative Markers Can Correlate With Vascularity in Specific Areas of the Glioblastoma Tissue and Predict Recurrence', 'orgStudyIdInfo': {'id': 'DCE_MRI_GBM'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Dynamic contrast-enhanced MRI', 'type': 'OTHER', 'description': 'Dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI) is the acquisition of sequential images during the passage of a contrast agent within a tissue of interest.'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cairo', 'country': 'Egypt', 'facility': 'Department of Neurosurgery, Cairo University Faculty of Medicine', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Egyptian Medical Syndicate', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Mohammed A. Azab', 'investigatorAffiliation': 'Cairo University'}}}}