Ignite Creation Date:
2025-12-24 @ 7:15 PM
Ignite Modification Date:
2026-01-07 @ 9:09 AM
Study NCT ID:
NCT03102203
Status:
UNKNOWN
Last Update Posted:
2017-04-05
First Post:
2017-03-24
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Differentiation of Progression From Treatment Effects in High-Grade Gliomas: A Clinical Trial With Multimodality MR Imaging
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': 350}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-06-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-03', 'completionDateStruct': {'date': '2018-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-03-30', 'studyFirstSubmitDate': '2017-03-24', 'studyFirstSubmitQcDate': '2017-03-30', 'lastUpdatePostDateStruct': {'date': '2017-04-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-04-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Ktrans', 'timeFrame': 'baseline', 'description': 'The volume transfer constant in dynamic contrast-enhanced MR Imaging'}, {'measure': 'Ktrans', 'timeFrame': '3 months', 'description': 'The volume transfer constant in dynamic contrast-enhanced MR Imaging'}, {'measure': 'Ktrans', 'timeFrame': '10 months', 'description': 'The volume transfer constant in dynamic contrast-enhanced MR Imaging'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Glioma']}, 'descriptionModule': {'briefSummary': 'To evaluate the efficacy of multi-modality magnetic resonance quantitative parameters in evaluating the treatment effects of high-grade gliomas, and to provide new biomarkers for the establishment of new diagnostic criteria for the identification of true and pseudoprogression of high-grade gliomas.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The Eligibility module specifies the criteria for determining which people are (or are not) eligible to participate in the study', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients with high-grade gliomas confirmed by pathology and have not been treated with concurrent chemoradiotherapy;\n2. Written informed consent is obtained.\n\nExclusion Criteria:\n\n1. Patients not suitable for enhanced MRI scanning of patients;\n2. Patients who have not finished follow-up concurrent chemoradiotherapy or MR scanning.'}, 'identificationModule': {'nctId': 'NCT03102203', 'briefTitle': 'Differentiation of Progression From Treatment Effects in High-Grade Gliomas: A Clinical Trial With Multimodality MR Imaging', 'organization': {'class': 'OTHER', 'fullName': 'Jinling Hospital, China'}, 'officialTitle': 'Differentiation of Progression From Treatment Effects in High-Grade Gliomas: A Prospective Multicenter Clinical Trial With Multimodality MR Imaging', 'orgStudyIdInfo': {'id': 'NanjingJH01'}}, 'contactsLocationsModule': {'locations': [{'zip': '210002', 'city': 'Nanjing', 'state': 'Jiangsu', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Zhiqiang Zhang, Doctor', 'role': 'CONTACT', 'email': 'zhangzq2001@126.com', 'phone': '+86 13913885490'}], 'facility': 'Jinling Hospital', 'geoPoint': {'lat': 32.06167, 'lon': 118.77778}}], 'centralContacts': [{'name': 'Yuan Xie, Master', 'role': 'CONTACT', 'email': 'cheryl050914@163.com', 'phone': '+86 13584099838'}], 'overallOfficials': [{'name': 'Guang Ming Lu, Doctor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Jinling Hospital, China'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jinling Hospital, China', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Lu Guang Ming', 'investigatorAffiliation': 'Jinling Hospital, China'}}}}