Clinical Trial

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

Study acronym: AIDALOS-III
Active, Not Recruiting
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Summary
The goal of this clinical trial is to verify the opportunistic screening potential of the AI software for detection of brain unruptured intracranial aneurysms (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 UIA on brain NECT scans? The performance and the clinical use of the AI algorithm will be measured based on the number of UIA detected by the AI software compared to the number of UIA confirmed by review of a radiologist compared to the number of UIA already known by review of the electronic patient file/additional diagnostic research. 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). Furthermore, patient outcomes, complications/death related to the possible (un)ruptured brain aneurysm will be assessed 5 years after study enrolment.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2025-08-07.
Status change: Not Yet Recruiting → Active, Not Recruiting 2026-01-08
Trial Details
NCT Number NCT07123818
Lead Sponsor Ziekenhuis Oost-Limburg
Collaborators: Robovision BV, Universitair Ziekenhuis Brussel, General Hospital Groeninge
Conditions Intracranial Aneurysm
Enrollment 10 participants
Start Date 2025-10-24
Primary Completion 2025-12-09 (estimated)
Study Completion 2030-12-31 (estimated)
Updated on ClinicalTrials.gov 2026-01-12