Ignite Creation Date:
2025-12-24 @ 4:15 PM
Ignite Modification Date:
2026-01-01 @ 11:25 PM
Study NCT ID:
NCT01598766
Status:
UNKNOWN
Last Update Posted:
2013-02-05
First Post:
2012-05-11
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
General Investigative MRI Protocol
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2012-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-02', 'completionDateStruct': {'date': '2020-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2013-02-04', 'studyFirstSubmitDate': '2012-05-11', 'studyFirstSubmitQcDate': '2012-05-11', 'lastUpdatePostDateStruct': {'date': '2013-02-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-05-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '16 Channel Flex Coil', 'timeFrame': 'May 2012-May 2013', 'description': 'The 16 Channel Flex Coil will be evaluated for how well it performs on pediatric patients.'}], 'secondaryOutcomes': [{'measure': '8 Channel Value Breast Coil', 'timeFrame': '6 months', 'description': 'clinical evaluation to determine if an 8 channel mri breast coil meets industry standards.'}]}, 'conditionsModule': {'conditions': ['Multiple MRI Exams, Including', 'Cardiac', 'Abdominal', 'Lumbar', 'Neck', 'Pelvis']}, 'descriptionModule': {'briefSummary': "This study is a feasibility study to evaluate new technology to improve the MRI experience, with coils, sequences and software. Patients from the Principle Investigator's exam schedule are given the opportunity to participate in this study is their MRI exam is appropriate for the specific coil, sequence or software being evaluated. If they agree, they can receive their MRI exam with the new coil, sequence or software instead of the standard one."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '6 Months', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Pediatric patients that are scheduled for a clinically necessary MRI exam provided the subject meets the criteria of the department MRI screening procedure and their study is appropriate for the use of the 4 Channel Flex SPEEDER coil of the 16 Channel Metaflex SPEEDER coil.\n\nExclusion Criteria:\n\n* Any contraindication to MRI procedures'}, 'identificationModule': {'nctId': 'NCT01598766', 'briefTitle': 'General Investigative MRI Protocol', 'organization': {'class': 'INDUSTRY', 'fullName': 'Toshiba America Medical Systems, Inc.'}, 'officialTitle': 'General Investigational Protocol for EXCELART VANTAGE ZGV/XGV/AGV/ ATLAS/XGV/ZGV TITAN/XGV VANTAGE TITAN 3T', 'orgStudyIdInfo': {'id': '05069'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Diagnostic Coil', 'description': 'This coil is a lightweight, flexible coil which can be used for many pediatric MRI exams', 'interventionNames': ['Device: 16 Channel SPEEDER Flex Coil']}], 'interventions': [{'name': '16 Channel SPEEDER Flex Coil', 'type': 'DEVICE', 'description': 'This is a 16 element MRI coil, flexible, lightweight. Multiple uses.', 'armGroupLabels': ['Diagnostic Coil']}]}, 'contactsLocationsModule': {'locations': [{'zip': '89052', 'city': 'Henderson', 'state': 'Nevada', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Erin Kelly, PhD', 'role': 'CONTACT', 'email': 'ekelly@tams.com', 'phone': '714-604-6242'}, {'name': 'Mark L Winkler, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Steinberg Diagnostic Medical Imaging', 'geoPoint': {'lat': 36.0397, 'lon': -114.98194}}], 'centralContacts': [{'name': 'Erin Kelly', 'role': 'CONTACT', 'email': 'ekelly@tams.com', 'phone': '7146046242'}], 'overallOfficials': [{'name': 'Mark L Winkler, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Steinberg Diagnostic Medical Imaging'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Toshiba America Medical Systems, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}