Ignite Creation Date:
2025-12-24 @ 3:56 PM
Ignite Modification Date:
2026-01-01 @ 9:17 AM
Study NCT ID:
NCT00727792
Status:
COMPLETED
Last Update Posted:
2020-01-21
First Post:
2008-07-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Refinement and Assessment of New MRI Technologies for Thoracic/ Cardiovascular Exams
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-01', 'completionDateStruct': {'date': '2019-04-16', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-01-17', 'studyFirstSubmitDate': '2008-07-28', 'studyFirstSubmitQcDate': '2008-08-01', 'lastUpdatePostDateStruct': {'date': '2020-01-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2008-08-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-04-16', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'New MRI Technologies', 'timeFrame': '3 years', 'description': 'Assessment of the new technologies will be quantified by a variety of performance and image quality/content measures. The appropriate set of measures will be selected based on specific features offered by each assessed technology, but will be drawn from the following quantities:\n\n1. Scan speed: Scan speed is time required to set-up and run the new technique relative to the standard method.\n2. Signal to noise: SNR (signal to noise ratio)is the ratio of average image intensity in target tissue relative to standard deviation of background areas (outside of body). This is a fundamental parameter used to quantify relative performance of new imaging sequences/hardware/software.\n3. Contrast to noise: CNR (contrast to noise)is the difference in average image intensity between two target tissues relative to noise. This is a key descriptor to quantity lesion/tissue conspicuity, thus is used to characterize relative performance of new imaging sequence/hardware/software.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['participants', 'scheduled', 'clinically', 'ordered', 'MRI'], 'conditions': ['Magnetic Resonance Imaging (MRI) of the Chest']}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to improve chest MRI exams, eventually resulting in improvements in patient care.', 'detailedDescription': 'We will recruit patients to participate in the assessment of new MRI technologies designed to improve chest MRI exams that will result in improvements in patient care.\n\nSeveral different MRI technologies will be evaluated. Specific evaluation of distinct technologies (eg. new head coil design, and new imaging sequence for the spine) may be evaluated simultaneously, or over non-overlapping periods in time.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* If you are a male or a non-pregnant female patient, age 18 years or older, of any ethnic background presenting to MRI for a clinically-ordered chest MRI exam, you are eligible to participate in this study.\n* If you are a female of child bearing potential you will be questioned for the possibility of pregnancy. Pregnancy screening, if necessary, is performed routinely by ordering physicians prior to MRI scanning to confirm the patient is not pregnant.\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 nursing\n* Patients who are claustrophobic.'}, 'identificationModule': {'nctId': 'NCT00727792', 'briefTitle': 'Refinement and Assessment of New MRI Technologies for Thoracic/ Cardiovascular Exams', 'organization': {'class': 'OTHER', 'fullName': 'University of Michigan'}, 'officialTitle': 'Refinement and Assessment of New MRI Technologies for Thoracic/ Cardiovascular Exams', 'orgStudyIdInfo': {'id': 'HUM00041514'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group 2 - Research MRI', 'description': 'Subjects will have additional sequences and/or modification to MRI sequences.', 'interventionNames': ['Procedure: MRI-Research']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group 1 - Clinical MRI', 'description': 'Clinically ordered MRI scan. Subjects will not have any additional sequences or modifications to their clinically ordered MRI', 'interventionNames': ['Procedure: MRI -Clinical']}], 'interventions': [{'name': 'MRI -Clinical', 'type': 'PROCEDURE', 'description': 'MRI done is standard of care', 'armGroupLabels': ['Group 1 - Clinical MRI']}, {'name': 'MRI-Research', 'type': 'PROCEDURE', 'description': 'MRI includes extra sequences', 'armGroupLabels': ['Group 2 - Research MRI']}]}, 'contactsLocationsModule': {'locations': [{'zip': '48109', 'city': 'Ann Arbor', 'state': 'Michigan', 'country': 'United States', 'facility': 'University of Michigan Hospital', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}], 'overallOfficials': [{'name': 'Jadranka Stojanovska, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Michigan'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Michigan', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Jadranka Stojanovska, M.D., M.S.', 'investigatorAffiliation': 'University of Michigan'}}}}