Ignite Creation Date:
2025-12-24 @ 7:23 PM
Ignite Modification Date:
2026-01-05 @ 1:38 AM
Study NCT ID:
NCT00599703
Status:
COMPLETED
Last Update Posted:
2009-07-08
First Post:
2008-01-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Language Function in Patients With Brain Tumors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001932', 'term': 'Brain Neoplasms'}, {'id': 'D016543', 'term': 'Central Nervous System Neoplasms'}], 'ancestors': [{'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D007854', 'term': 'Lead'}], 'ancestors': [{'id': 'D019216', 'term': 'Metals, Heavy'}, {'id': 'D004602', 'term': 'Elements'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D008670', 'term': 'Metals'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 7}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-07', 'completionDateStruct': {'date': '2009-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-07-07', 'studyFirstSubmitDate': '2008-01-11', 'studyFirstSubmitQcDate': '2008-01-11', 'lastUpdatePostDateStruct': {'date': '2009-07-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-01-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To identify language organization prior to surgery in patients in whom a tumor invades or is directly adjacent to the expected location of one of the language centers.', 'timeFrame': 'conclusion of study'}], 'secondaryOutcomes': [{'measure': 'To assess language reorganization over time.', 'timeFrame': 'conclusion of study'}]}, 'conditionsModule': {'conditions': ['Brain Cancer', 'CNS Cancer']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.mskcc.org', 'label': 'Memorial Sloan-Kettering Cancer Center'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to use an imaging method called functional magnetic resonance imaging (fMRI) in patients who have a tumor near an area of the brain that is believed to control language. The fMRI is a new kind of imaging that uses a strong magnetic field to look at functioning brain tissue. This kind of imaging will be used to study the effect of the brain tumor on your speech.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'MSKCC clinics', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patient in whom a tumor invades or is directly adjacent to the expected location of one of the language centers.\n* At least 18 years of age\n* English as first language\n\nExclusion Criteria:\n\n* Patients with high grade tumors\n* History of significant psychiatric condition (e.g. schizophrenia, obsessive-compulsive disorder, significant dementia),\n* History of the following neurological conditions: CVA, demyelinating conditions, cerebral palsy, Alzheimer's disease.\n* History of significant claustrophobic reactions.\n* Pregnancy\n* Standard contraindications to MR examinations (e.g. implanted stimulator)\n* Patients, who were treated prior to our first scan, will not be eligible to participate in this study"}, 'identificationModule': {'nctId': 'NCT00599703', 'briefTitle': 'Language Function in Patients With Brain Tumors', 'organization': {'class': 'OTHER', 'fullName': 'Memorial Sloan Kettering Cancer Center'}, 'officialTitle': 'Reorganization of Language Function in Patients With Brain Tumors', 'orgStudyIdInfo': {'id': '05-043'}}, 'armsInterventionsModule': {'armGroups': [{'label': '1', 'description': 'neurosurgical patients', 'interventionNames': ['Other: fMRI Scan, pre- and post language evaluation']}], 'interventions': [{'name': 'fMRI Scan, pre- and post language evaluation', 'type': 'OTHER', 'description': 'All subjects will undergo functional MR imaging, pre- and post-surgical language evaluation, and electrocortical stimulation mapping. The brain tumor patients will undergo these procedures twice.', 'armGroupLabels': ['1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10065', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Memorial Sloan Kettering Cancer Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'Andrei Holodny, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Memorial Sloan Kettering Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Memorial Sloan Kettering Cancer Center', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Andrei Holodny, M.D.', 'oldOrganization': 'Memorial Sloan-Kettering Cancer Center'}}}}