Ignite Creation Date:
2025-12-26 @ 4:01 PM
Ignite Modification Date:
2026-02-24 @ 5:03 PM
Study NCT ID:
NCT02769806
Status:
TERMINATED
Last Update Posted:
2023-01-17
First Post:
2016-05-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Advanced Perfusion MRI of Treatment Response and Progression in 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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 16}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'funding', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2016-05-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-01', 'completionDateStruct': {'date': '2019-06-21', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-01-12', 'studyFirstSubmitDate': '2016-05-10', 'studyFirstSubmitQcDate': '2016-05-10', 'lastUpdatePostDateStruct': {'date': '2023-01-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-05-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-06-21', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'A novel high resolution DSC-PWI imaging method', 'timeFrame': '2 years', 'description': 'A novel high resolution DSC-PWI method will be compared to the standard DSC-PWI method to determine whether novel method improves image quality in tumor regions.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Glioblastoma', 'Glioblastoma Multiforme']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://cancer.wisc.edu/', 'label': 'UW Carbone Cancer Center Home Page'}]}, 'descriptionModule': {'briefSummary': 'The primary aim of this project is to Compare new msCS and standard DSC-PWI methods in GBM patients undergoing post-operative MRI for monitoring of tumor progression.', 'detailedDescription': 'Investigators will compare the novel to the standard DSC-PWI methods in twenty five GBM patients to determine whether novel method improves image quality in tumor regions. We will also compare accuracy of pseudoprogression (PsP) vs. early progressive disease (ePD) determinations by the two techniques. If successful, the project will culminate in a novel imaging method sequence optimized to monitor progression and guide treatment decisions in post-operative GBM patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '82 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'A total of 25 patients diagnosed with GBM will be enrolled and stratified by the methylation status of their tumor; 17 MGMT-unmethylated and 8 MFMT-methylated will be enrolled.', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Histology: Glioblastoma (grade 4 astrocytoma)\n* Standard-of-care, post-gd T1w image changes suggestive or consistent with of progression.\n* Standard-of-care MRI included conventional DSC-PWI without unexpected technical difficulties.\n* Methylation status of tumor available in medical record.\n* Able to provide written informed consent.\n\nExclusion Criteria:\n\n* Contraindications either to 3T MRI (e.g. certain metallic and electronic implants, claustrophobia) or IV gadolinium contrast (allergy, pregnancy, breast-feeding, renal insufficiency). Screening for these contraindications will be based on history only (as it is for all routine outpatient clinical MRI at UWHC).\n* Significant physical or mental disease which would preclude successful compliance and participation in the study or, in the opinion of the principal investigator, or co-investigator, constitute a hazard, such that enrollment in the study would not be in the patient's best interest.\n* Special subjects such as minors, mentally disabled persons, or prisoners."}, 'identificationModule': {'nctId': 'NCT02769806', 'briefTitle': 'Advanced Perfusion MRI of Treatment Response and Progression in Glioblastoma', 'organization': {'class': 'OTHER', 'fullName': 'University of Wisconsin, Madison'}, 'officialTitle': 'Advanced Perfusion MRI of Treatment Response and Progression in Glioblastoma', 'orgStudyIdInfo': {'id': 'UW15098'}, 'secondaryIdInfos': [{'id': '2016-0007', 'type': 'OTHER', 'domain': 'Institutional Review Board'}, {'id': 'A539300', 'type': 'OTHER', 'domain': 'UW Madison'}, {'id': 'SMPH\\RADIOLOGY\\RADIOLOGY', 'type': 'OTHER', 'domain': 'UW Madison'}, {'id': 'NCI-2019-06444', 'type': 'REGISTRY', 'domain': 'NCI Trial ID'}, {'id': 'R21EB018483-01A1', 'link': 'https://reporter.nih.gov/quickSearch/R21EB018483-01A1', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'GBM patients undergoing MRI', 'description': 'GBM patients undergoing standard-of-care post-operative combination chemoRT and clinically indicated MRI including standard DSC-PWI for follow-up.', 'interventionNames': ['Procedure: MRI']}], 'interventions': [{'name': 'MRI', 'type': 'PROCEDURE', 'armGroupLabels': ['GBM patients undergoing MRI']}]}, 'contactsLocationsModule': {'locations': [{'zip': '53792', 'city': 'Madison', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'University of Wisconsin Carbone Cancer Center', 'geoPoint': {'lat': 43.07305, 'lon': -89.40123}}], 'overallOfficials': [{'name': 'Alexey Samsonov', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Wisconsin, Madison'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Currently, there is no plan to share data.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Wisconsin, Madison', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute for Biomedical Imaging and Bioengineering (NIBIB)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}