Trials / Active Not Recruiting
Active Not RecruitingNCT07123818
AI for Detection of Brain Aneurysm: Low-cost Opportunistic Screening
- Status
- Active Not Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 10 (actual)
- Sponsor
- Ziekenhuis Oost-Limburg · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | AI software | 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, after approval of the subject, which will detect possible unruptured intracranial aneurysms (UIA). NECT scans on which a possibe UIA has been detected will be transferred to a platform on which involved radiologist can verify the AI result(s). |
Timeline
- Start date
- 2025-10-24
- Primary completion
- 2025-12-09
- Completion
- 2030-12-31
- First posted
- 2025-08-14
- Last updated
- 2026-01-12
Locations
4 sites across 1 country: Belgium
Source: ClinicalTrials.gov record NCT07123818. Inclusion in this directory is not an endorsement.