Ignite Creation Date:
2025-12-24 @ 11:51 PM
Ignite Modification Date:
2025-12-25 @ 9:46 PM
Study NCT ID:
NCT06201351
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-01-11
First Post:
2023-11-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study of Adaptive Radiotherapy for High-grade Glioma Based on Interfraction MRI
Sponsor:
Organization:
Raw JSON
{'hasResults': False, '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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-01-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-12', 'completionDateStruct': {'date': '2026-09-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-01-10', 'studyFirstSubmitDate': '2023-11-28', 'studyFirstSubmitQcDate': '2024-01-10', 'lastUpdatePostDateStruct': {'date': '2024-01-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-01-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Homogeneity index', 'timeFrame': 'up to 2 weeks', 'description': 'HI: Homogeneity index. Dosimetric change'}, {'measure': 'conformity index', 'timeFrame': 'up to 2 weeks', 'description': 'CI: conformity index. Dosimetric change'}, {'measure': 'Anatomic change', 'timeFrame': 'up to 2 weeks', 'description': 'Dmax Volume'}], 'secondaryOutcomes': [{'measure': 'progression-free survival (PFS)', 'timeFrame': 'assessed up to 12 months', 'description': 'progression-free survival'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['adaptive radiotherapy', 'high-grade glioma', 'MRI image'], 'conditions': ['High-grade Glioma']}, 'descriptionModule': {'briefSummary': 'The changes of target and organs at risk in patients with high-grade glioma during concurrent chemoradiotherapy were evaluated by MRI image between radiotherapy fractions.', 'detailedDescription': 'To prospectively evaluate the changes of target organs and risk organs in patients with high-grade glioma during concurrent chemoradiotherapy.The related factors causing this change are discussed.The relationship between changes and patient survival was analyzed.A predictive model was established to provide individualized adaptive radiotherapy for patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with high-grade glioma confirmed by pathology in our hospital and treated with standard STUPP regimen.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age ≥18 years old;\n2. High-grade glioma was confirmed by pathology after surgery;\n3. ECOG score 0-2 points;\n4. Receiving the standard STUPP regimen (i.e. 6 weeks of temozolomide concurrent chemoradiotherapy +6 cycles of temozolomide adjuvant chemotherapy);\n5. Baseline data available.\n\nExclusion Criteria:\n\n1. The pathological diagnosis is not clear;\n2. No synchronous chemotherapy/adjuvant chemotherapy \\< 6 cycles;\n3. There are other malignant tumors;\n4. Previously radiotherapy to the head;\n5. Interruption of radiotherapy for more than 5 days;\n6. Failure to collect baseline data.'}, 'identificationModule': {'nctId': 'NCT06201351', 'briefTitle': 'Study of Adaptive Radiotherapy for High-grade Glioma Based on Interfraction MRI', 'organization': {'class': 'OTHER', 'fullName': 'West China Hospital'}, 'officialTitle': 'Study of Adaptive Radiotherapy for High-grade Glioma Based on Interfraction Magnetic Resonance Imaging (MRI)', 'orgStudyIdInfo': {'id': 'Trial No. 1460, 2023'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Adaptive radiotherapy group', 'description': 'MRI was performed and adaptive radiotherapy was administered at farction10 and fraction 20 during radiotherapy.', 'interventionNames': ['Device: adaptive radiotherapy']}], 'interventions': [{'name': 'adaptive radiotherapy', 'type': 'DEVICE', 'otherNames': ['ART'], 'description': 'MRI was performed and adaptive radiotherapy was administered at farction10 and fraction 20 during radiotherapy.', 'armGroupLabels': ['Adaptive radiotherapy group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '610041', 'city': 'Chengdu', 'state': 'Sichuan', 'country': 'China', 'contacts': [{'name': 'Biomedical Ethics Review Committee, West China Hospital', 'role': 'CONTACT', 'email': 'aip2023@163.com', 'phone': '8685423237'}, {'name': 'Ping Ai, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'West China Hospital', 'geoPoint': {'lat': 30.66667, 'lon': 104.06667}}], 'centralContacts': [{'name': 'Ping Ai, MD', 'role': 'CONTACT', 'email': 'aip2023@163.com', 'phone': '18980602055'}, {'name': 'Shuangshuang He', 'role': 'CONTACT', 'email': 'hess9707@163.com', 'phone': '18708178816'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'West China Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Professor', 'investigatorFullName': 'Ping Ai', 'investigatorAffiliation': 'West China Hospital'}}}}