Ignite Creation Date:
2025-12-24 @ 6:44 PM
Ignite Modification Date:
2025-12-24 @ 6:44 PM
Study NCT ID:
NCT04302857
Status:
COMPLETED
Last Update Posted:
2022-06-10
First Post:
2020-03-06
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Tractography Pilot Study Leipzig
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001932', 'term': 'Brain Neoplasms'}], '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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-06', 'completionDateStruct': {'date': '2021-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-06-07', 'studyFirstSubmitDate': '2020-03-06', 'studyFirstSubmitQcDate': '2020-03-06', 'lastUpdatePostDateStruct': {'date': '2022-06-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-03-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Neurological Performance', 'timeFrame': 'three months', 'description': 'Neurological Performance Score (NPS)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Intracranial Neoplasm']}, 'referencesModule': {'references': [{'pmid': '37646398', 'type': 'DERIVED', 'citation': 'Wende T, Hoffmann A, Scherlach C, Kasper J, Sander C, Arlt F, Dietel E, Stockert A, Meixensberger J, Prasse G. Preserved White Matter Integrity and Recovery After Brain Tumor Surgery: A Prospective Pilot Study on the Frontal Aslant Tract. Brain Connect. 2023 Dec;13(10):589-597. doi: 10.1089/brain.2023.0033. Epub 2023 Oct 19.'}]}, 'descriptionModule': {'briefSummary': 'In this pilot study participants will undergo routine magnetic resonance imaging and routine neurosurgical care. By prospectively collecting data from both MRI and patient records we want to investigate biomarkers derived from tractography and diffusion tensor imaging to predict rehabilitation potential.', 'detailedDescription': 'Patients will undergo MRI before and after surgery with DTI. With CSD-tractography, fiber bundles and their volumes will be identified. By measuring fractional anisotropy (FA) within these volumes, a correlation with clinical outcome and recovery will be tested. Also, FA frequency distributions will be used to describe white matter integrity and to thereby improve future tractography algorithms. Fiber bundles of interest will be the arcuate fascicle (AF), the corticospinal tract (CST), frontal aslant tract (FAT), the inferior fronto-occipital fascicle (IFOF), the inferior longitudinal fascicle (ILF) and the uncinate fascicle (UF).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Standard cohort of neurosurgical patients', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* intracranial lesion\n* elective neurosurgical procedure\n\nExclusion Criteria:\n\n* MRI not applicable\n* cerebral ischemia during study period\n* pregnancy during study period\n* encephalitis during study period\n* spontaneous intracerebral hemorrhage during study period'}, 'identificationModule': {'nctId': 'NCT04302857', 'briefTitle': 'Tractography Pilot Study Leipzig', 'organization': {'class': 'OTHER', 'fullName': 'University of Leipzig'}, 'officialTitle': 'Pilot Study for Establishing Perioperative Tractography at Leipzig University Neurosurgery', 'orgStudyIdInfo': {'id': '322/19-ek'}}, 'armsInterventionsModule': {'interventions': [{'name': 'routine MRI', 'type': 'OTHER', 'description': 'MRI with routine DTI sequence'}]}, 'contactsLocationsModule': {'locations': [{'zip': '04103', 'city': 'Leipzig', 'state': 'Saxony', 'country': 'Germany', 'facility': 'Leipzig University Hospital, Department of Neurosurgery', 'geoPoint': {'lat': 51.33962, 'lon': 12.37129}}], 'overallOfficials': [{'name': 'Jürgen Meixensberger, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'University of Leipzig'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tim Wende', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Tim Wende', 'investigatorAffiliation': 'University of Leipzig'}}}}