AI for Detection of Brain Aneurysm: Low-cost Opportunistic Screening

Not Applicable

Not yet recruiting

• Conditions: Intracranial Aneurysm

• Registration Number: NCT07123818
• Lead Sponsor: Ziekenhuis Oost-Limburg

Brief Summary

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.

The 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?

The 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.

Participants will be followed-up following Standard-of-Care (SoC). In addition, participants will be requested to complete a questionnaire (the EQ-5D-5L questionnaire).

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-05
• Study First Submitted: 2025-06-02
• Study First Submitted QC: 2025-08-07
• Last Update Submitted: 2025-08-07
• Study First Posted: 2025-08-14
• Last Update Posted: 2025-08-14
• Study Start: 2025-09-01
• Primary Completion: 2025-12-15
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 10000

Inclusion Criteria

• the subject of the NECT scan must be an adult patient (Age ≥ 18 years old);
• the NECT scan must be a NECT scan from the brain;
• the NECT scan must contain the entire brain;
• signed written informed consent must be obtained before follow-up data will be gathered, if applicable.

Exclusion Criteria

• There are no specific exclusion criteria.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Verify the opportunistic screening potential of the AI software for detection of brain UIA on routinely performed brain NECT scans in a prospective setting	Through study completion, an average of 3 months

Secondary Outcome Measures

Name	Time	Method
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.	Through study completion, an average of 3 months.
Measure the health-related quality of life of patients by completion of the EQ-5D-5L questionnaire.	Through study completion, an average of 3 months. Questionnaire gathered one month after signing ICF.