Ignite Creation Date:
2025-12-24 @ 3:27 PM
Ignite Modification Date:
2025-12-25 @ 2:26 PM
Study NCT ID:
NCT01549392
Status:
TERMINATED
Last Update Posted:
2014-09-15
First Post:
2012-02-17
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Imaging Study of Glioblastomas Treated With Avastin
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005910', 'term': 'Glioma'}], '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D009682', 'term': 'Magnetic Resonance Spectroscopy'}, {'id': 'D056324', 'term': 'Diffusion Tensor Imaging'}], 'ancestors': [{'id': 'D013057', 'term': 'Spectrum Analysis'}, {'id': 'D002623', 'term': 'Chemistry Techniques, Analytical'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D059906', 'term': 'Neuroimaging'}, {'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D038524', 'term': 'Diffusion Magnetic Resonance Imaging'}, {'id': 'D008279', 'term': 'Magnetic Resonance Imaging'}, {'id': 'D014054', 'term': 'Tomography'}, {'id': 'D003943', 'term': 'Diagnostic Techniques, Neurological'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'barbara.fisher@lhsc.on.ca', 'phone': '519-685-8650', 'title': 'Barbara Fisher', 'organization': 'London Health Sciences Hospital'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'DECT/MRS in Patients Receiving Avastin', 'description': '-15 Glioma Patients with progression will undergo DECT and MRS pre-Avastin and 3 months later\n\nDECT: DECT at tumor progression and 3 months later\n\nMR spectroscopy: MR spectroscopy at tumor progression and 3 months later', 'otherNumAtRisk': 3, 'otherNumAffected': 0, 'seriousNumAtRisk': 3, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'DECT/MRS in Glioma Patients Not Receiving Avastin', 'description': '15 glioma patients not receiving Avastin for recurrence studied in the same manner as Arm 1\n\nDECT: DECT at tumor progression and 3 months later\n\nMR spectroscopy: MR spectroscopy at tumor progression and 3 months later', 'otherNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '1'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': '3 Month Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'DECT/MRS in Patients Receiving Avastin', 'description': '-15 Glioma Patients with progression will undergo DECT and MRS pre-Avastin and 3 months later\n\nDECT: DECT at tumor progression and 3 months later\n\nMR spectroscopy: MR spectroscopy at tumor progression and 3 months later'}, {'id': 'OG001', 'title': 'DECT/MRS in Glioma Patients Not Receiving Avastin', 'description': '15 glioma patients not receiving Avastin for recurrence studied in the same manner as Arm 1\n\nDECT: DECT at tumor progression and 3 months later\n\nMR spectroscopy: MR spectroscopy at tumor progression and 3 months later'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'at 3 months after initial DECT and MR spectroscopy', 'description': 'participants who had reduction of tumor size from avastin at 3 months', 'unitOfMeasure': 'participants who had tumor reduction', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'DECT/MRS in Patients Receiving Avastin', 'description': '3 Glioma Patients underwent DECT and MRS pre-Avastin and 3 months later after receiving avastin 10 mg/kg iv q2weeks\n\nDECT: DECT at tumor progression and 3 months later\n\nMR spectroscopy: MR spectroscopy at tumor progression and 3 months later Avastin 10 mg/kg iv q2weeks'}, {'id': 'FG001', 'title': 'DECT/MRS in Glioma Patients Not Receiving Avastin', 'description': '0 glioma patients not receiving Avastin for recurrence studied in the same manner as Arm 1\n\nDECT: DECT at tumor progression and 3 months later\n\nMR spectroscopy: MR spectroscopy at tumor progression and 3 months later'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'DECT/MRS in Patients Receiving Avastin', 'description': '-15 Glioma Patients with progression will undergo DECT and MRS pre-Avastin and 3 months later\n\nDECT: DECT at tumor progression and 3 months later\n\nMR spectroscopy: MR spectroscopy at tumor progression and 3 months later'}, {'id': 'BG001', 'title': 'DECT/MRS in Glioma Patients Not Receiving Avastin', 'description': '15 glioma patients not receiving Avastin for recurrence studied in the same manner as Arm 1\n\nDECT: DECT at tumor progression and 3 months later\n\nMR spectroscopy: MR spectroscopy at tumor progression and 3 months later'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '50', 'groupId': 'BG000', 'lowerLimit': '45', 'upperLimit': '65'}, {'value': '50', 'groupId': 'BG002', 'lowerLimit': '45', 'upperLimit': '65'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Age, Categorical', 'classes': [{'title': '<=18 years', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG002'}]}]}, {'title': 'Between 18 and 65 years', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG002'}]}]}, {'title': '>=65 years', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Gender', 'classes': [{'title': 'Female', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG002'}]}]}, {'title': 'Male', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Canada', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'patients with recurrent glioblastoma'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 3}}, 'statusModule': {'whyStopped': 'insufficient accrual', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2012-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-09', 'completionDateStruct': {'date': '2014-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-09-11', 'studyFirstSubmitDate': '2012-02-17', 'resultsFirstSubmitDate': '2014-04-02', 'studyFirstSubmitQcDate': '2012-03-06', 'lastUpdatePostDateStruct': {'date': '2014-09-15', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2014-09-11', 'studyFirstPostDateStruct': {'date': '2012-03-09', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-09-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '3 Month Response', 'timeFrame': 'at 3 months after initial DECT and MR spectroscopy', 'description': 'participants who had reduction of tumor size from avastin at 3 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['dynamic enhanced ct scan', 'mri spectroscopy', 'recurrent gliomas'], 'conditions': ['Malignant Gliomas']}, 'descriptionModule': {'briefSummary': 'This study aims to assess the effect of Avastin on brain vascularity and blood-brain permeability using dynamic contrast ct scans (DECT) and MRI imaging. Previous publications have documented the method by which DECT can determine alterations in vascular volume and tissue permeability within tumors and normal brain tissue. Functional maps of cerebral blood flow cerebral blood volume and permeability-surface area can be generated from the DECT studies to assess tumor perfusion. MRI spectroscopy analyzes brain chemistry to detect tumour versus edema versus normal brain. Thirty patients will receive MRI spectroscopy and DECT imaging at the time of presumed recurrence and 3 months later. 15 patients who do not receive Avastin and 15 patients who do receive Avastin as standard treatment for recurrence will be studied with DECT and MRI spectroscopy at baseline and then again in 3 months.', 'detailedDescription': 'The clinical determination of the point of tumour progression or response is difficult to determine using standard diagnostic imaging ie CT/MRI especially following previous treatment with surgery, radiation and chemotherapy. Hemorrhage, edema, inflammation and vascular necrosis.\n\nBoth MR spectroscopy and DECT have been reported as being able to define areas of recurrent tumour as opposed to treatment-related effects. We wish to investigate the correlation between MR spectroscopy and DECT in assessing tumour progression or response to Avastin in comparison with patients not receiving Avastin.\n\nHealth Canada has approved Avastin for clinical use in patients with recurrent glioblastoma who have previously received temozolomide and radiotherapy. We propose to perform a DECT scan at baseline at presumed tumour progression and again 3 months to determine the effects of tumour progression/response on blood brain barrier permeability and vascular volume. The group of 15 patients will be compared to a group of 15 patients who do not receive Avastin at recurrence involving DECT scanning and MR spectroscopy at the time of the radiological progression and 3 months later.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Histological diagnosis of glioblastoma with clinical or radiological evidence of progression as indicated by the RANO criteria 19\n* Previous radiation and temozolomide chemotherapy\n* Patients must be receiving Avastin chemotherapy as second-line treatment if in the Avastin group\n* Study-specific consent\n\nExclusion Criteria:\n\n* Failure to meet inclusion criteria\n* Pregnant or lactating patients\n* Allergy to iodine or CT contrast precludes DECT component of study\n* Claustrophobia precludes MR Spectroscopy component of study\n* Internal metal which would preclude an MRI scan'}, 'identificationModule': {'nctId': 'NCT01549392', 'briefTitle': 'Imaging Study of Glioblastomas Treated With Avastin', 'organization': {'class': 'OTHER', 'fullName': 'London Health Sciences Centre'}, 'officialTitle': 'Feasibility Study of Magnetic Resonance Spectroscopy and Dynamic Enhanced Cat Scan Imaging in Glioblastomas Treated With and Without Avastin', 'orgStudyIdInfo': {'id': 'LRCP02'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'DECT/MR Spectroscopy +Avastin', 'description': '-15 Glioma Patients with progression will undergo DECT and MRS before Avastin (10 mg/kg iv q2 weeks until progression) and 3 months later', 'interventionNames': ['Device: DECT', 'Device: MR spectroscopy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'DECT/MR Spectroscopy no Avastin', 'description': '15 glioma patients not receiving Avastin for recurrence studied in the same manner as Arm 1', 'interventionNames': ['Device: DECT', 'Device: MR spectroscopy']}], 'interventions': [{'name': 'DECT', 'type': 'DEVICE', 'otherNames': ['3 T 64-slice CT scanner (Discovery CT750 HD, GE Healthcare'], 'description': 'DECT at tumor progression and 3 months later', 'armGroupLabels': ['DECT/MR Spectroscopy +Avastin', 'DECT/MR Spectroscopy no Avastin']}, {'name': 'MR spectroscopy', 'type': 'DEVICE', 'otherNames': ['MRI scanner: Siemens 3T Tim Trio', 'Sequences: T1W, DTI', 'Analysis software: Brain voyager'], 'description': 'MR spectroscopy at tumor progression and 3 months later', 'armGroupLabels': ['DECT/MR Spectroscopy +Avastin', 'DECT/MR Spectroscopy no Avastin']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'N6A4L6', 'city': 'London', 'state': 'Ontario', 'country': 'Canada', 'facility': 'London Regional Cancer Centre', 'geoPoint': {'lat': 42.98339, 'lon': -81.23304}}], 'overallOfficials': [{'name': 'Barbara J Fisher, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'London Regional Cancer Program'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'London Health Sciences Centre', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Western Ontario, Canada', 'class': 'OTHER'}, {'name': 'London Regional Cancer Program, Canada', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr', 'investigatorFullName': 'Barbara Fisher', 'investigatorAffiliation': 'London Health Sciences Centre'}}}}