Ignite Creation Date:
2025-12-25 @ 5:01 AM
Ignite Modification Date:
2026-03-01 @ 10:10 AM
Study NCT ID:
NCT02091518
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2025-10-29
First Post:
2014-03-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Development and Evaluation of Magnetic Resonance Imaging Acquisition and Analysis Methods
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': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 461}}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2014-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2026-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-10-27', 'studyFirstSubmitDate': '2014-03-14', 'studyFirstSubmitQcDate': '2014-03-18', 'lastUpdatePostDateStruct': {'date': '2025-10-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-03-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'feasibility of new MRI applications', 'timeFrame': '5 years', 'description': 'This protocol will provide pilot data to determine the feasibility of development and optimization of new MRI acquisition and analysis method.including sequence development, optimization, and workflow and analysis/visualization tools. An investigator will view the conventional images, as well as the additional research sequences. The radiologist will then complete data forms for each image and quantitative values, as listed in the evaluation form will be recorded. After all images have been read, the radiologist will review the clinical images together with the research images, and determine whether the research sequences had any effect on their diagnostic confidence.'}]}, 'conditionsModule': {'keywords': ['MRI', '13-239', 'volunteers', 'patients'], 'conditions': ['Healthy']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.mskcc.org/', 'label': 'Memorial Sloan Kettering Cancer Center'}]}, 'descriptionModule': {'briefSummary': 'Magnetic resonance imaging (MRI) is a diagnostic imaging method with constant progress and improvement in the way the MRI images are obtained. Many of these advances involve changes to MRI software and hardware. The goal of this study is to find out the possible benefits of new MRI techniques. This will allow us to use the new MRI methods in research and patient care.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Men and women age 18 or older\n\nExclusion Criteria:\n\n* Anyone who would be normally excluded from undergoing an MRI examination as per Memorial Hospital for Cancer and Allied Diseases Screening Questionnaire for MRI\n* Patients/volunteers with a pacemaker, aneurysm clip or any other condition that would warrant avoidance of a strong magnetic field\n* Female patients/ volunteers who are pregnant or nursing\n* Patients/ volunteers who are unable to comply or complete the MRI exam due to claustrophobia or high levels of anxiety\n* Patients/ volunteers from the vulnerable population, as defined by 45 CFR 46.\n* Patients at higher risk due to age, frailty, or the emergent nature of their condition'}, 'identificationModule': {'nctId': 'NCT02091518', 'briefTitle': 'Development and Evaluation of Magnetic Resonance Imaging Acquisition and Analysis Methods', 'organization': {'class': 'OTHER', 'fullName': 'Memorial Sloan Kettering Cancer Center'}, 'officialTitle': 'Development and Evaluation of Magnetic Resonance Imaging Acquisition and Analysis Methods', 'orgStudyIdInfo': {'id': '13-239'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'MRI', 'description': 'Add-On Research Patients will include patients who are scheduled for a routine clinical MRI who meet the eligibility requirements for this protocol. Protocol participation will consist of an "add-on" research. MRI scan, which will be performed any point during of the routine clinical MRI scan.\n\nVolunteers will be subjects expressing interest in participation and who meet the eligibility requirements for this protocol. No contrast enhanced research MRIs including gadolinium-based or other contrast agents will be performed in volunteers.', 'interventionNames': ['Behavioral: MR Screening Questionnaire', 'Device: Magnetic Resonance Imaging Acquisition and Analysis']}], 'interventions': [{'name': 'MR Screening Questionnaire', 'type': 'BEHAVIORAL', 'description': 'All participants will complete the MR Screening Questionnaire before the MRI exam. During the MRI exam, all participants will be observed through the window from the operator console. Verbal communication will be kept with the participant throughout the exam via a speaker system.', 'armGroupLabels': ['MRI']}, {'name': 'Magnetic Resonance Imaging Acquisition and Analysis', 'type': 'DEVICE', 'description': 'MRI Studies: The MRI scans will be performed on a 1.5T or 3T MRI scanner. Conventional MRI studies will be performed using the standard clinical sequences. The new research sequences will be performed.at any point during the clinical exam. Total imaging time for volunteers will be 30-45 minutes.', 'armGroupLabels': ['MRI']}]}, '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': 'Oguz Akin, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Memorial Sloan Kettering Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Memorial Sloan Kettering Cancer Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'Ceretype', 'class': 'UNKNOWN'}, {'name': 'University of California, San Diego', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}