Ignite Creation Date:
2025-12-24 @ 4:47 PM
Ignite Modification Date:
2025-12-27 @ 1:23 AM
Study NCT ID:
NCT05287750
Status:
RECRUITING
Last Update Posted:
2022-03-18
First Post:
2022-01-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Brain Diseases on 7.0T Magnetic Resonance Imaging
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001932', 'term': 'Brain Neoplasms'}, {'id': 'D002561', 'term': 'Cerebrovascular Disorders'}], 'ancestors': [{'id': 'D016543', 'term': 'Central Nervous System Neoplasms'}, {'id': 'D009423', 'term': 'Nervous System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008279', 'term': 'Magnetic Resonance Imaging'}], 'ancestors': [{'id': 'D014054', 'term': 'Tomography'}, {'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-03', 'completionDateStruct': {'date': '2026-09-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-03-15', 'studyFirstSubmitDate': '2022-01-07', 'studyFirstSubmitQcDate': '2022-03-15', 'lastUpdatePostDateStruct': {'date': '2022-03-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-03-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-09-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'the correspondence between brain tumor cells found in the biopsies and region of interest(ROI) signal intension on the 7T MRI scan and 3T MRI scan', 'timeFrame': 'within a month after biopsy', 'description': "Pathological assessment of biopsy material compared with the lesion's contrast-enhancement signal intension to normal brain white mater on 7T MRI and 3T MRI"}, {'measure': 'The visibility of white matter tracts on 7T MRI', 'timeFrame': 'within a month after biopsy', 'description': 'Visualization of white matter tracts will be done with the use of diffusion tensor imaging (DTI) on 7T MRI and measuring the mean diffusivity (MD) value on Post-processing workstation ,and analysis the correlation between these values and pathological.'}], 'secondaryOutcomes': [{'measure': "The correlation between the ROI's signal intension on 7T MRI scan and the KPS in 1 month after operation", 'timeFrame': 'within a month after biopsy', 'description': 'The correlation analysis between the T1 contrast-enchanced signal intension, Regional cerebral blood flow on 7T MRI (clinical sequence and perfusion) scan and the KPS in 1 month after operation'}, {'measure': 'The visibility of white matter tracts on 7T MRI and 3T MRI', 'timeFrame': 'Six months after the biopsy', 'description': 'Visualization of white matter tracts will be done with the use of diffusion tensor imaging (DTI) on 7T MRI and 3T MRI. and analysis the difference of the mean diffusivity (MD) value between 7.0T MRI and 3.0T MRI'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Brain tumor', 'Cerebrovascular disease', 'MRI', 'Ultra high field'], 'conditions': ['Brain Tumor', 'MRI', 'Cerebrovascular Disease']}, 'referencesModule': {'references': [{'pmid': '40397837', 'type': 'DERIVED', 'citation': 'Duan Q, Lyu J, Liu Z, Hao F, Li R, Liu S, Hao X, Li J, Bian X, Duan C, Wang S, Wang W, Wang R, Duan L, Lou X. Noninvasive Assessment of the Risk Features of Hemorrhage in Moyamoya Disease Using 7T MRI. Neurology. 2025 Jun 10;104(11):e213617. doi: 10.1212/WNL.0000000000213617. Epub 2025 May 21.'}, {'pmid': '37559435', 'type': 'DERIVED', 'citation': 'Duan C, Bian X, Cheng K, Lyu J, Xiong Y, Xiao S, Wang X, Duan Q, Li C, Huang J, Hu J, Wang ZJ, Zhou X, Lou X. Synthesized 7T MPRAGE From 3T MPRAGE Using Generative Adversarial Network and Validation in Clinical Brain Imaging: A Feasibility Study. J Magn Reson Imaging. 2024 May;59(5):1620-1629. doi: 10.1002/jmri.28944. Epub 2023 Aug 9.'}]}, 'descriptionModule': {'briefSummary': 'This clinical trial studies the use of 7-Tesla (7T)and 3T magnetic resonance imaging (MRI) in detecting brain diseases. 7T MRI has increased detection sensitivity, including more accurate lesion delineation, higher inter-rater agreement. Diagnostic procedures such as 7T MRI may help ultimately improved diagnostic and therapies confidence to inform decision making than standard 3T MRI.', 'detailedDescription': '7T MRI increased detection sensitivity, attain superior anatomic resolution, higher spatial and spectral specificity of advanced quantitative techniques, and shorter scan times than 3T MRI. When applied clinically, these benefits translate to increased detection sensitivity, and ultimately improved diagnostic and therapies confidence to inform decision making. This study aim to detect the image characteristics and diagnostic accuracy of brain diseases on 7T MRI.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age≥18 and ≤80\n* Having brain diseases (eg: brain tumor, cerebrovascular diseases)\n* Having no contraindications against MRI or intravenous contrast agent administration\n* Clinically stable\n\nExclusion Criteria:\n\n* Age\\<18 or \\>80\n* Pregnancy and other contraindication to MRI scan\n* Informed consent not obtained'}, 'identificationModule': {'nctId': 'NCT05287750', 'briefTitle': 'Brain Diseases on 7.0T Magnetic Resonance Imaging', 'organization': {'class': 'OTHER', 'fullName': 'Chinese PLA General Hospital'}, 'officialTitle': 'Brain Diseases on 7.0T Magnetic Resonance Imaging', 'orgStudyIdInfo': {'id': 'Brain Diseases-ChinaPLAGH'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Magnetic resonance imaging', 'type': 'DIAGNOSTIC_TEST', 'description': 'Patients recruited will receive Magnetic resonance imaging.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '100853', 'city': 'Beijing', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Kun Cheng, M.S.', 'role': 'CONTACT', 'email': 'dr_chengkun@163.com', 'phone': '+8619921784434'}], 'facility': 'Chinese PLA General Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Kun Cheng, M.S.', 'role': 'CONTACT', 'email': 'dr_chengkun@163.com', 'phone': '+86 19921784434'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chinese PLA General Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director and Clinical Professor', 'investigatorFullName': 'Xin Lou', 'investigatorAffiliation': 'Chinese PLA General Hospital'}}}}