Ignite Creation Date:
2025-12-24 @ 5:18 PM
Ignite Modification Date:
2026-03-26 @ 12:33 AM
Study NCT ID:
NCT02687750
Status:
COMPLETED
Last Update Posted:
2016-02-22
First Post:
2016-02-02
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Testing of Radiofrequency Coil for Clinical 19F MRI
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 4}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-02', 'completionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-02-16', 'studyFirstSubmitDate': '2016-02-02', 'studyFirstSubmitQcDate': '2016-02-16', 'lastUpdatePostDateStruct': {'date': '2016-02-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-02-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Verify radio frequency coil imaging functionality on humans', 'timeFrame': '1 hour of scanning', 'description': 'Proof of successful MRI signal acquisition with use of investigation device.'}, {'measure': 'Measure signal repeatability in different patients', 'timeFrame': '1 hour of scanning', 'description': 'MRI signal strength is expected to vary slightly based on patient weight.'}]}, 'conditionsModule': {'conditions': ['Diagnostic Imaging']}, 'descriptionModule': {'briefSummary': 'Testing of a dual tuned proton/fluorine MRI radio frequency coil\n\nImages were collected from plastic fluorine phantoms taped to the upper thigh of health volunteers.\n\nThis trial was performed as part of an application for a Health Canada Investigational Device Exemption (Protocol # 226949)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy Volunteer\n\nExclusion Criteria:\n\n* MRI incompatible patient\n* claustrophobia'}, 'identificationModule': {'nctId': 'NCT02687750', 'briefTitle': 'Testing of Radiofrequency Coil for Clinical 19F MRI', 'organization': {'class': 'OTHER', 'fullName': 'Western University, Canada'}, 'orgStudyIdInfo': {'id': 'RRI-PF-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'MRI', 'description': 'Eppendorf tubes containing 10% fluorine-19 diluted in agar were taped to the upper thigh of participants. Investigational device was used to image the phantom with Magnetic resonance imaging (MRI). Imaging was performed for anatomical (proton) and fluorine (agent detection). Total scan time was under 1 hour.\n\nObjectives:\n\n* Verify RF coil functionality\n* Obtain preliminary detection threshold limits using a human coil loading', 'interventionNames': ['Device: MRI']}], 'interventions': [{'name': 'MRI', 'type': 'DEVICE', 'description': 'Investigational device is a dual tuned (fluorine/proton) MRI surface coil designed and produced by Clinical MR solutions', 'armGroupLabels': ['MRI']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Western University, Canada', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Paula Foster', 'investigatorAffiliation': 'Western University, Canada'}}}}