Ignite Creation Date:
2025-12-24 @ 9:26 PM
Ignite Modification Date:
2026-02-20 @ 6:38 PM
Study NCT ID:
NCT06727032
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2025-08-03
First Post:
2024-12-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Automated Detection of Brain Metastases on MRI
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001932', 'term': 'Brain Neoplasms'}], '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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 12}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2025-01-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2025-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-01', 'studyFirstSubmitDate': '2024-12-05', 'studyFirstSubmitQcDate': '2024-12-05', 'lastUpdatePostDateStruct': {'date': '2025-08-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-12-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Detection accuracy', 'timeFrame': '3 months', 'description': 'Demonstrate that the accuracy for detecting brain metastases by radiologists on MRI using the software (AIDED) is at least non-inferior to that of radiologists not using the software (UNAIDED).'}], 'secondaryOutcomes': [{'measure': 'Reading time', 'timeFrame': '3 months', 'description': 'Demonstrate that the AIDED radiologists reading time for detecting brain metastases is significantly lower than for UNAIDED radiologists.'}, {'measure': 'Inter-reader agreement', 'timeFrame': '3 months', 'description': 'Demonstrate that AIDED reading reduces detection variation between observers/readers in brain metastasis detection.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Brain Metastases']}, 'descriptionModule': {'briefSummary': 'This reader study aims at assessing whether the radiologist aided with AI software has at least a non-inferior performance than without AI assistance in detecting brain metastases.\n\n200 retrospective MRI images will be included in the study with 100 positive and 100 negative exams.\n\nAssessment will be completed by 12 readers with varying level of experience. This is a Retrospective Multiple-Reader Multiple-Case (MRMC) randomised study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Brain Metastasis', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* subjects older than 18 years with a known or possible primary extracranial cancer who undergo MRI for diagnosis, treatment planning or follow-up of brain metastases.\n\nExclusion Criteria:\n\n* subjects with primary intracranial tumor(s), with more than 10 brain metastases, with meningeal metastases, with radiation necrosis, or post brain surgery'}, 'identificationModule': {'nctId': 'NCT06727032', 'acronym': 'BrainMets AI', 'briefTitle': 'Automated Detection of Brain Metastases on MRI', 'organization': {'class': 'INDUSTRY', 'fullName': 'Robovision BV'}, 'officialTitle': 'Validation of an AI Software for Detection of Brain Metastases on MRI: AIDED Versus UNAIDED Performance', 'orgStudyIdInfo': {'id': 'CI-2024-BrainMetsAI'}, 'secondaryIdInfos': [{'id': 'IRBd20-090', 'type': 'OTHER', 'domain': 'IRB NKI-AVL'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'Brain Metastasis AI', 'type': 'DEVICE', 'description': 'There will be no intervention'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Amsterdam', 'country': 'Netherlands', 'facility': 'Netherlands Cancer Institute', 'geoPoint': {'lat': 52.37403, 'lon': 4.88969}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Robovision BV', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Netherlands Cancer Institute - NKI', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}