Ignite Creation Date:
2025-12-24 @ 11:10 PM
Ignite Modification Date:
2025-12-25 @ 8:43 PM
Study NCT ID:
NCT04629469
Status:
RECRUITING
Last Update Posted:
2025-02-11
First Post:
2020-10-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Low Field and High Field Magnetic Resonance Imaging Assessments on Pediatric Patients
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': 250}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-07', 'studyFirstSubmitDate': '2020-10-27', 'studyFirstSubmitQcDate': '2020-11-13', 'lastUpdatePostDateStruct': {'date': '2025-02-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-11-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Sensitivity and specificity of hyperfine MRI versus conventional MRI, CT and/or US', 'timeFrame': 'Through study completion, an average of one year', 'description': 'Sensitivity and specificity of hyperfine MRI versus conventional MRI, CT and/or US'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Conditions Requiring a Brain Magnetic Resonance Imaging, Head Computerized Tomography, or Head Ultrasound']}, 'referencesModule': {'references': [{'pmid': '35788031', 'type': 'DERIVED', 'citation': 'Sien ME, Robinson AL, Hu HH, Nitkin CR, Hall AS, Files MG, Artz NS, Pitts JT, Chan SS. Feasibility of and experience using a portable MRI scanner in the neonatal intensive care unit. Arch Dis Child Fetal Neonatal Ed. 2023 Jan;108(1):45-50. doi: 10.1136/archdischild-2022-324200. Epub 2022 Jul 4.'}]}, 'descriptionModule': {'briefSummary': "Hyperfine Research, Inc. has taken advantage of technological advances and developed an MRI device that is not only portable, but also uses a very-low magnetic field strength, \\[less than 0.2 Tesla or approximately 10 times less\\] than the field strength of conventional devices. This critical difference allows HRI to address MRI's core challenges by, first, operating at very low magnetic field strengths, eliminating the need for special rooms or shielding. Second, there are minimal safety concerns regarding ferrous metals near the system, as the field strength is too low to attract metal objects. The removal of metal, including items such as jewelry, belts, etc. from clothing and person, prior to being scanned, is unnecessary. Third, the design constraints faced by conventional MRI systems are lifted at low magnetic field and an open device has been designed to minimize anxiety that may come with claustrophobic patients. All of this is possible while still providing image quality that is clinically relevant to a wide variety of fields, including radiology, neurology, pediatrics, emergency medicine, and others."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '22 Years', 'minimumAge': '0 Days', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria\n\nInpatients at CMH Adele Hall ages 0 days to 22 years are eligible for enrollment.\n\nExclusion Criteria\n\nNo additional sedation will be given as part of this study and that sedation, if already administered, will not be altered for study purposes.\n\nAny patient who has a contraindication to having an MRI, such as:\n\nNon-MRI conditional implanted device or device that is not able to be removed for MRI examination'}, 'identificationModule': {'nctId': 'NCT04629469', 'briefTitle': 'Low Field and High Field Magnetic Resonance Imaging Assessments on Pediatric Patients', 'organization': {'class': 'OTHER', 'fullName': "Children's Mercy Hospital Kansas City"}, 'officialTitle': 'Low Field and High Field Magnetic Resonance Imaging Assessments on Pediatric Patients', 'orgStudyIdInfo': {'id': 'STUDY00001356'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Hyperfine', 'description': 'For patients that have standard of care head imaging, we will do a secondary analysis to compare their standard of care MRI, CT and/or US exams with Hyperfine MRI exams.', 'interventionNames': ['Diagnostic Test: Hyperfine MRI']}], 'interventions': [{'name': 'Hyperfine MRI', 'type': 'DIAGNOSTIC_TEST', 'description': "• Patients who have a standard of care MRI, CT or US will undergo a low-field MRI utilizing Hyperfine either at the patient's bedside or in the department of Radiology. Results of the Hyperfine MRI will not be used for clinical care and will only be available to members of the research team for review.", 'armGroupLabels': ['Hyperfine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '64108', 'city': 'Kansas City', 'state': 'Missouri', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Maura Sien, BS,RT(R)', 'role': 'CONTACT', 'email': 'mesien@cmh.edu', 'phone': '8163026065'}, {'name': 'Sarah Foster', 'role': 'CONTACT', 'email': 'ssfoster@cmh.edu', 'phone': '8162343273'}, {'name': 'Sherwin Chan, MD,PHD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "Children's Mercy Hospital", 'geoPoint': {'lat': 39.09973, 'lon': -94.57857}}], 'centralContacts': [{'name': 'Maura Sien, MS,RT(R)', 'role': 'CONTACT', 'email': 'mesien@cmh.edu', 'phone': '8163028311'}], 'overallOfficials': [{'name': 'Sherwin Chan, MD,PHD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Children's Mercy Kansas City"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Children's Mercy Hospital Kansas City", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Sherwin Chan MD PhD', 'investigatorAffiliation': "Children's Mercy Hospital Kansas City"}}}}