Ignite Creation Date:
2025-12-25 @ 4:48 AM
Ignite Modification Date:
2025-12-26 @ 3:50 AM
Study NCT ID:
NCT07123818
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-08-14
First Post:
2025-06-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
AI for Detection of Brain Aneurysm: Low-cost Opportunistic Screening
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002532', 'term': 'Intracranial Aneurysm'}, {'id': 'D000783', 'term': 'Aneurysm'}], 'ancestors': [{'id': 'D020765', 'term': 'Intracranial Arterial Diseases'}, {'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Prospective multicentric interventional study design'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 10000}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-09-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-07', 'studyFirstSubmitDate': '2025-06-02', 'studyFirstSubmitQcDate': '2025-08-07', 'lastUpdatePostDateStruct': {'date': '2025-08-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-08-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Verify the opportunistic screening potential of the AI software for detection of brain UIA on routinely performed brain NECT scans in a prospective setting', 'timeFrame': 'Through study completion, an average of 3 months'}], 'secondaryOutcomes': [{'measure': 'Verify the percentage of patients that underwent treatment(s) of the UIA after detection of the possible UIA by the AI software, confirmation of possible UIA by the radiologist, and definitive diagnosis of the UIA, by review of the EPD.', 'timeFrame': 'Through study completion, an average of 3 months.'}, {'measure': 'Measure the health-related quality of life of patients by completion of the EQ-5D-5L questionnaire.', 'timeFrame': 'Through study completion, an average of 3 months. Questionnaire gathered one month after signing ICF.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Aneurysm', 'Intracranial', 'UIA', 'Unruptured'], 'conditions': ['Intracranial Aneurysm']}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to verify the opportunistic screening potential of the AI software for detection of brain UIA on routinely performed brain NECT scans in a prospective setting in the Belgian population.\n\nThe main question the study aims to answer is: Does the AI algorithm has potential to be used as clinical screening potential for detection of brain anerysms on brain NECT scans?\n\nThe performance and the clinical use of the AI algorithm will be measured based on the number of aneurysms detected by the software compared to the number of aneurysms confirmed by review of a radiologist compared to the number of aneurysms already known by review of the electronic patient file.\n\nParticipants will be followed-up following Standard-of-Care (SoC). In addition, participants will be requested to complete a questionnaire (the EQ-5D-5L questionnaire).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* the subject of the NECT scan must be an adult patient (Age ≥ 18 years old);\n* the NECT scan must be a NECT scan from the brain;\n* the NECT scan must contain the entire brain;\n* signed written informed consent must be obtained before follow-up data will be gathered, if applicable.\n\nExclusion Criteria:\n\n\\- There are no specific exclusion criteria.'}, 'identificationModule': {'nctId': 'NCT07123818', 'acronym': 'AIDALOS-III', 'briefTitle': 'AI for Detection of Brain Aneurysm: Low-cost Opportunistic Screening', 'organization': {'class': 'OTHER', 'fullName': 'Ziekenhuis Oost-Limburg'}, 'officialTitle': 'AI for Detection of Brain Aneurysm: Low-cost Opportunistic Screening', 'orgStudyIdInfo': {'id': 'Z-2025021'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Brain NECT scans with possible UIA detected by AI software and radiologist', 'description': 'Patients that have had a brain NECT scans on which the AI software detected a possible unruptured intracranial brain aneurysm (UIA) and which the radologist confirmed as possible UIA can participate in the study. They are requested to sign Informed Consent Form (ICF) after which follow-up data regarding the untruptured intracranial aneurysm (UIA) will be gathered.', 'interventionNames': ['Device: AI software']}], 'interventions': [{'name': 'AI software', 'type': 'DEVICE', 'description': 'AI software that will verify brain NECT scans on the presence of unruptured intracranial aneurysms (UIA). Brain NECT scans will be send to the AI software which will detect possible unruptured intracranial aneurysms (UIA). NECT scans on which a possibe UIA has been detected will be send to a platform on which involved radiologist can verify the AI result(s).', 'armGroupLabels': ['Brain NECT scans with possible UIA detected by AI software and radiologist']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ziekenhuis Oost-Limburg', 'class': 'OTHER'}, 'collaborators': [{'name': 'Robovision BV', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}