Ignite Creation Date:
2025-12-24 @ 11:42 PM
Ignite Modification Date:
2026-02-20 @ 12:41 PM
Study NCT ID:
NCT03847051
Status:
COMPLETED
Last Update Posted:
2023-10-17
First Post:
2019-02-12
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
EPIMix Versus CT Brain Pediatric Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001927', 'term': 'Brain Diseases'}], 'ancestors': [{'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 15}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-02-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-10', 'completionDateStruct': {'date': '2022-07-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-10-13', 'studyFirstSubmitDate': '2019-02-12', 'studyFirstSubmitQcDate': '2019-02-18', 'lastUpdatePostDateStruct': {'date': '2023-10-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-02-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-03-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Tolerance of a new fast MR method in children', 'timeFrame': 'At 0 hours', 'description': 'Number of aborted MR'}, {'measure': 'Diagnostic potential', 'timeFrame': 'At 0 hours', 'description': 'Diagnostic accuracy to categorize scan as normal or abnormal on a five point Likert scale (1 - definitely normal, 2 - Probably normal, 3 - Indeterminate, 4 - Probably abnormal, 5 - Definitely abnormal) compared to abnormal/normal brain CT.'}], 'secondaryOutcomes': [{'measure': 'Lesion classification', 'timeFrame': 'At 0 hours', 'description': 'Classification into disease categories (Neoplastic, Ischemic, Hemorrhagic, Infection, Neuroinflammation, Hydrocephalus, Congenital malformation, Indeterminate)'}, {'measure': 'Lesion location determination', 'timeFrame': 'At 0 hours', 'description': 'Anatomical localization of abnormality (Cerebrum, Cerebellum, Brainstem, Intraventricular, Subarachnoid space including basal cisterns, Intra-orbital, Skull/Skull base/dural, Other)'}, {'measure': 'Diagnostic imaging quality', 'timeFrame': 'At 0 hours', 'description': 'Diagnostic imaging quality (5 point Likert scale; 1 - Excellent diagnostic imaging quality, 2 - Good diagnostic imaging quality, 3 - Sufficient diagnostic imaging quality, 4 - Restricted diagnostic imaging quality, 5 - Poor diagnostic imaging quality)'}, {'measure': 'Lesion description', 'timeFrame': 'At 0 hours', 'description': 'For example effect on brain parenchyma and size'}, {'measure': 'Diagnostic confidence', 'timeFrame': 'At 0 hours', 'description': 'Five point Likert scale (Very confident, Predominantly confident, Fairly confident, Only slightly confident, Not at all confident)'}, {'measure': 'Clinical diagnostic summary report', 'timeFrame': 'At 0 hours', 'description': 'Text (one sentence summary of the finding including type of lesion and location)'}, {'measure': 'Ability to rule out diseases', 'timeFrame': 'At 0 hours', 'description': 'A list of diseases. Number of positive versus negative cases for each investigation (including: Tumor, Abscess, Parenchymal Haemorrhage, Acute Ischemia, Hydrocephalus, Neuroinflammation, Subarachnoid hemorrhage, Extraaxial fluid collection)'}, {'measure': 'Artefacts', 'timeFrame': 'At 0 hours', 'description': 'Artefacts and impact (Motion, Beam hardening, Other) defined as; Not present, Not affecting diagnostic confidence, Degrading diagnostic confidence)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['MRI (magnetic resonance imaging)', 'Neuroradiology', 'EPIMix (Echo planar imaging mix)', 'Multicontrast EPI (echo planar imaging)', 'Clinical validation'], 'conditions': ['Brain Diseases']}, 'referencesModule': {'references': [{'pmid': '38267889', 'type': 'DERIVED', 'citation': 'De Luca F, Kits A, Martin Munoz D, Aspelin A, Kvist O, Osterman Y, Diaz Ruiz S, Skare S, Falk Delgado A. Elective one-minute full brain multi-contrast MRI versus brain CT in pediatric patients: a prospective feasibility study. BMC Med Imaging. 2024 Jan 24;24(1):23. doi: 10.1186/s12880-024-01196-6.'}]}, 'descriptionModule': {'briefSummary': 'This study aims to assess the diagnostic feasibility and diagnostic performance of a new fast MR sequence EPIMix for neuroradiological evaluation in comparison to computed tomography of brain in pediatric population.', 'detailedDescription': 'The study aims to assess the feasibility of fast MR sequence for neuroradiological evaluation in comparison to computed tomography of brain in pediatric population. Imaging quality is analysed with regards to artefacts and lesion conspicuity as well as its diagnostic potential in rendering a probable diagnosis. The primary study aim is to define feasibility and the AUC for diagnostic performance of minute MRI compared to computed tomography.\n\nIncluded patients are children age 4-18 with suspicion of cerebral pathology with referral to elective computed tomography of the brain.\n\nStudy participants are in addition to computed tomography investigated during same day at 3T MR.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '4 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Child with indication for elective brain CT.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 4-18 years.\n* Patient with suspicion of cerebral pathology.\n* Referral to elective brain CT study.\n\nExclusion Criteria:\n\n* CT planned with sedation\n* known previous cerebral pathology (follow up study)\n* Emergency CT\n* Aborted MR exam'}, 'identificationModule': {'nctId': 'NCT03847051', 'briefTitle': 'EPIMix Versus CT Brain Pediatric Study', 'organization': {'class': 'OTHER', 'fullName': 'Karolinska University Hospital'}, 'officialTitle': 'EPIMix (Echo Planar Imaging Mix) Versus CT Brain Pediatric Study', 'orgStudyIdInfo': {'id': 'EPIMix pediatric'}}, 'armsInterventionsModule': {'interventions': [{'name': 'MRI', 'type': 'DIAGNOSTIC_TEST', 'description': 'Brain MRI without intravenous contrast'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Stockholm', 'country': 'Sweden', 'facility': 'Karolinska University Hospital', 'geoPoint': {'lat': 59.32938, 'lon': 18.06871}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Karolinska University Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'GE Healthcare', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator, Medical doctor, PhD, Specialist in Neuroradiology', 'investigatorFullName': 'Anna Falk Delgado', 'investigatorAffiliation': 'Karolinska University Hospital'}}}}