Ignite Creation Date:
2025-12-25 @ 5:03 AM
Ignite Modification Date:
2026-03-03 @ 8:42 AM
Study NCT ID:
NCT00739518
Status:
COMPLETED
Last Update Posted:
2021-03-15
First Post:
2008-08-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Refinement and Assessment of New Magnetic Resonance Imaging Technologies for Neurological Exams
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}], 'ancestors': [{'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 500}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-03', 'completionDateStruct': {'date': '2020-01-14', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-03-11', 'studyFirstSubmitDate': '2008-08-20', 'studyFirstSubmitQcDate': '2008-08-20', 'lastUpdatePostDateStruct': {'date': '2021-03-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2008-08-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2020-01-14', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Improvement in quality of MRI studies in Neuroradiology', 'timeFrame': '1 year', 'description': "Specific Measurement Are:\n\n1. Scan speed - is the new method as fast or faster than regular method(s)\n2. Signal to noise - Subjectively, or quantitatively do we get the same, better, or new contrast compared to the regular methods(s).\n3. Image contrast - Subjectively, or quantitatively do we get the same or better resolution compared to the regular method(s).\n4. Spatial resolution - Subjectively, or quantitatively do we get the same or better resolution compared to the regular method(s).\n5. Artifact - Subjectively, or quantitatively do we get the better artifact reduction compared to the regular method(s).\n6. Ergonomics - Is the new software easier to work or offer more information more cleanly than the regular software\n7. Patient comfort - Subjectively, does the new software and/or hardware make the patient's MRI experience more comfortable."}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Neurological', 'MRI'], 'conditions': ['Nervous System Diseases']}, 'descriptionModule': {'briefSummary': 'This study is being done to assess new Magnetic Resonance Imaging (MRI) technologies such as new hardware or software designed to improve MRI examinations of the brain, spine head and neck regions.', 'detailedDescription': 'This study is being done to assess new Magnetic Resonance Imaging (MRI) technologies such as new hardware or software designed to improve MRI examinations of the brain, spine, and head \\& neck regions.\n\nSoftware and hardware are constantly being improved, new machines replace old machines, software is updated and improved as are the devices used to produce better MRI images.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* If you are a male or a non-pregnant female patient\n* Normal volunteer\n* presenting to MRI for a clinically-ordered neurological or head and neck MRI exam\n\nExclusion Criteria:\n\n* Patients, who have electrically, magnetically or mechanically activated implants such as heart pacemaker, magnetic surgical clips, prostheses or implanted neurological stimulator.\n* Pregnant patients or patients who are lactating.\n* A patient who is claustrophobic'}, 'identificationModule': {'nctId': 'NCT00739518', 'briefTitle': 'Refinement and Assessment of New Magnetic Resonance Imaging Technologies for Neurological Exams', 'organization': {'class': 'OTHER', 'fullName': 'University of Michigan'}, 'officialTitle': 'Refinement and Assessment of New Magnetic Resonance Imaging (MRI) Technologies', 'orgStudyIdInfo': {'id': 'HUM00041731'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'MRI scan - new technology', 'description': "The patient's clinical MRI scan will also utilize some new technology, such as a change in software or additional MRI sequences", 'interventionNames': ['Procedure: MRI']}], 'interventions': [{'name': 'MRI', 'type': 'PROCEDURE', 'description': 'Neurological MRI with new technology evaluation. The new technology may involve software or MRI scanning sequences. This is a long term research study that focuses on new technology that is constantly being created.', 'armGroupLabels': ['MRI scan - new technology']}]}, 'contactsLocationsModule': {'locations': [{'zip': '48109', 'city': 'Ann Arbor', 'state': 'Michigan', 'country': 'United States', 'facility': 'University of Michigan Health System', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}], 'overallOfficials': [{'name': 'Ashok Srivinasan, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Michigan'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Michigan', 'class': 'OTHER'}, 'collaborators': [{'name': 'General Electric', 'class': 'INDUSTRY'}, {'name': 'Philips Medical Systems', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Ashok Srinivasan, M.D.', 'investigatorAffiliation': 'University of Michigan'}}}}