Ignite Creation Date:
2025-12-25 @ 3:45 AM
Ignite Modification Date:
2025-12-26 @ 2:31 AM
Study NCT ID:
NCT05776602
Status:
RECRUITING
Last Update Posted:
2023-10-17
First Post:
2023-02-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Fast Brain MRI in Children With Suspected Brain Tumor
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001932', 'term': 'Brain Neoplasms'}, {'id': 'D004194', 'term': 'Disease'}], 'ancestors': [{'id': 'D016543', 'term': 'Central Nervous System Neoplasms'}, {'id': 'D009423', 'term': 'Nervous System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-10', 'completionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-10-13', 'studyFirstSubmitDate': '2023-02-22', 'studyFirstSubmitQcDate': '2023-03-08', 'lastUpdatePostDateStruct': {'date': '2023-10-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-03-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Diagnostic performance', 'timeFrame': 'Through study completion, an average of 1 year', 'description': 'AUC, area under the curve for the comparison of the new method against the reference standard'}], 'secondaryOutcomes': [{'measure': 'Imaging artifacts', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'Image artifacts on both methods'}, {'measure': 'Imaging quality', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'Image quality on both methods'}, {'measure': 'Correlation', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'Correlation between readers and methods'}, {'measure': 'Agreement', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'Agreement between readers and methods'}, {'measure': 'Sensitivity', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'Sensitivity of the new method against the reference standard'}, {'measure': 'Specificity', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'Specificity of the new method against the reference standard'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Neuro', 'Imaging', 'MRI', 'Diagnostic accuracy', 'Neuroimaging', 'Fast MRI', 'Neuromix', 'Pediatric'], 'conditions': ['Magnetic Resonance Imaging', 'Brain Neoplasms, Childhood', 'Brain Neoplasms', 'Brain Tumor', 'Diagnosis', 'Image', 'Neuroimaging', 'Pediatric']}, 'descriptionModule': {'briefSummary': 'This study aims to assess the diagnostic performance of a new fast MRI sequence named Neuromix compared to routine clinical MRI for brain tumor in pediatric patients', 'detailedDescription': 'The study aims to assess the diagnostic performance of fast MR sequence for the radiological evaluation of brain tumor in comparison to routine clinical MRI (or reference standard) in a pediatric population.\n\nThe primary outcome is the depiction and characterization of normal brain, brain tumor pathology and incidental findings.\n\nSensitivity, specificity, AUC and intra-/ interreader agreement for the diagnostic performance of Neuromix compared to cMRI will be obtained. Correlation of results between methods will be calculated.\n\nSecondary outcomes will also include the assessment of diagnostic image quality and image artifacts.\n\nThe study population will consist of subjects aged 0-18 with a suspected or diagnosed brain tumor referred for routine MRI examination of the brain.\n\nStudy subjects will be investigated during the same day at 3T MR with Neuromix sequence in addition to the routine MRI examination.\n\nVolume measurements will be compared.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '1 Month', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Children up to 18 years with suspected or confirmed brain tumor investigated in standard clinical care with MRI of the brain.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 0-18 years.\n* Pediatric subjects with diagnosed or suspected brain tumor\n* Referral routine MRI study.\n\nExclusion Criteria:\n\n* MRI planned without sedation\n* Aborted MR exam\n* Unstable patient'}, 'identificationModule': {'nctId': 'NCT05776602', 'acronym': 'Fast MRI', 'briefTitle': 'Fast Brain MRI in Children With Suspected Brain Tumor', 'organization': {'class': 'OTHER', 'fullName': 'Karolinska University Hospital'}, 'officialTitle': 'Fast Brain MRI in Children With Suspected or Confirmed Brain Tumor', 'orgStudyIdInfo': {'id': 'Fast Brain MRI in children'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Pediatric patients with suspected or confirmed brain tumor', 'description': 'New method och standard MRI in clinical care', 'interventionNames': ['Diagnostic Test: Fast MRI (Neuromix)']}], 'interventions': [{'name': 'Fast MRI (Neuromix)', 'type': 'DIAGNOSTIC_TEST', 'description': 'Diagnostic performance, correlation, agreement', 'armGroupLabels': ['Pediatric patients with suspected or confirmed brain tumor']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'Eugeniavägen 3', 'city': 'Stockholm', 'status': 'RECRUITING', 'country': 'Sweden', 'contacts': [{'name': 'Anna Falk Delgado', 'role': 'CONTACT', 'email': 'anna.falk-delgado@neuroradkarolinska.se'}], 'facility': 'Karolinksa Universitetssjukhuset', 'geoPoint': {'lat': 59.32938, 'lon': 18.06871}}], 'centralContacts': [{'name': 'Anna Falk Delgado', 'role': 'CONTACT', 'email': 'anna.falk.delgado@ki.se', 'phone': '0046812370000'}], 'overallOfficials': [{'name': 'Anna Falk Delgado, Ass Prof', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Karolinska Institutet'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Karolinska University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, associate professor', 'investigatorFullName': 'Anna Falk Delgado', 'investigatorAffiliation': 'Karolinska University Hospital'}}}}