Ignite Creation Date:
2025-12-25 @ 2:38 AM
Ignite Modification Date:
2025-12-29 @ 2:59 PM
Study NCT ID:
NCT05188534
Status:
UNKNOWN
Last Update Posted:
2022-01-12
First Post:
2021-12-26
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
ZOOMit-fMRI Identifies Language Functional Cortex
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': 'CASE_CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2022-02-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-12', 'completionDateStruct': {'date': '2022-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-12-26', 'studyFirstSubmitDate': '2021-12-26', 'studyFirstSubmitQcDate': '2021-12-26', 'lastUpdatePostDateStruct': {'date': '2022-01-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-01-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-10-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The accurate rate for language related cortex localization with BOLD-fMRI and ZOOMit-fMRI', 'timeFrame': 'From scanning with BOLD-fMRI and ZOOMit-fMRI to getting the overlap indexes,assessed up to 2 weeks in each patient.', 'description': 'To illustrate the accurate rate of language functional cortex localization, the overlap indexes in BOLD-fMRI or ZOOMit-fMRI will be calculated. The results in BOLD-fMRI and ZOOMit-fMRI will be defined with 300 maximum value voxels via Statistical Parametric Mapping 8 (SPM8) software. According to the photographs and records of direct cortical stimulation (DCS) during awaken craniotomy, the DCS results will be confirmed as a global region with 5 mm diameter. Subsequently, the overlap of the BOLD-fMRI/ZOOMit-fMRI and DCS results will be calculated. In this way, the overlap indexes can be calculated as a ratio between the number of voxels overlapping and the number of total voxels in BOLD-fMRI and ZOOMit-fMRI. We defined if the overlap index is larger than 0, the localization result is accurate. In contrast, if the overlap index is equal to zero, the localization result is inaccurate. Finally, the accurate rate of language functional cortex localization can be calculated.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Language functional cortex', 'ZOOMit-fMRI'], 'conditions': ['Glioma']}, 'descriptionModule': {'briefSummary': 'This Study was designed to collect a series of patients with gliomas which were involved in language related cortex to analyze difference accuracy of language related cortex localization between BOLD-fMRI and ZOOMit-fMRI.', 'detailedDescription': "Gliomas can cause language dysfunction when they are involved in language related cortex. However, tumor resection also have risk to lead postoperatively language function deficits if destroy patients' language related cortex when tumor removed. Hence, it is important for neurosurgeon to realize the situation of patients' language related cortex locations in order to determine personal operative protocol.\n\nThe blood oxygen level dependent fMRI (BOLD-fMRI) is a prevalent preoperative method to localization language related cortex. It shows language relevant cortex by the change of blood oxygen level when patients cooperate to finish language tasks. The advantage of BOLD-fMRI includes higher time and spatial resolution, higher sensitivity, non-invasive. However, its accuracy of localization has not been satisfactory because neurovascular uncoupling. The ZOOMit-fMRI is a novel technic which is evolved from conventional BOLD-fMRI to localize language functional cortex.The advantage of ZOOMit-fMRI is smaller field of view (FOV) and higher spatial resolution comparing with BOLD-fMRI which helps to reduce other region of brain interference and elevate accuracy of localizations.\n\nIn this study, the investigators plan to enroll 60 patients, whose gliomas are involved in language related cortex, to acquire their BOLD-fMRI and ZOOMit-fMRI data in order to analyze their difference in the accuracy of language related cortex localization."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All patients with gliomas which are closed to language related area (Broca area and Wernicke area), treated by awake craniotomy and intraoperative brain mapping.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. age ≥ 18 years;\n2. no history of surgical treatment or radiotherapy;\n3. no contraindication to MRI scanning;\n4. agreeable to receive the fMRI scanning and awake craniotomy with DCS\n\nExclusion Criteria:\n\n1. basing on the anatomic MRI, the distance from the tumor to the hand-knob area lower than 20 mm;\n2. disable to finish the task of clenching fist during fMRI scanning.'}, 'identificationModule': {'nctId': 'NCT05188534', 'briefTitle': 'ZOOMit-fMRI Identifies Language Functional Cortex', 'organization': {'class': 'OTHER', 'fullName': 'Beijing Neurosurgical Institute'}, 'officialTitle': 'The Application of ZOOMit-fMRI to Identify Language Functional Cortex', 'orgStudyIdInfo': {'id': 'KYSB2016-026'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'BOLD-fMRI', 'description': 'Identifying the language functional cortex in glioma patients with BOLD-fMRI'}, {'label': 'ZOOMit-fMRI', 'description': 'Identifying the language functional cortex in glioma patients with ZOOMit-fMRI'}]}, 'contactsLocationsModule': {'locations': [{'zip': '100005', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'Beijing Neurosurgical Institute and Beijing Tiantan Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Tao Jiang, MD and Ph.D', 'role': 'CONTACT', 'email': 'taojiang1964@163.com', 'phone': '+86-010-67021832'}, {'name': 'Shengyu Fang, MD', 'role': 'CONTACT', 'phone': '+8613466331405'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Beijing Neurosurgical Institute', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}