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

NCT ID: NCT07123818

Last Updated: 2026-01-12

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-10-24
• Study Completion Date: 2030-12-31

Brief 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

Intracranial Aneurysm

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SCREENING
• Blinding Strategy: NONE

Study Groups

Brain NECT scans with possible UIA detected by AI software and radiologist

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 (= enrolled subjects). They are requested to sign Informed Consent Form (ICF) after which follow-up data regarding the untruptured intracranial aneurysm (UIA) will be gathered.

Group Type: OTHER

AI software

Intervention Type: DEVICE

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).

Interventions

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).

Intervention Type: DEVICE

Eligibility Criteria

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
• the patient should have at least one of the following risk factors for developing a brain aneurysm

• patient is female
• patient has a family history of brain aneurysms
• patient is 40 years or older
• patient has or is treated for a high blood pressure
• patient actively smokes cigarettes at time of inclusion
• a first informed consent form must be signed before brain NECT scans can be transferred to Robovision
• a second signed written informed consent must be obtained before follow-up data will be gathered, if applicable.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Robovision BV

INDUSTRY

Sponsor Role: collaborator

Universitair Ziekenhuis Brussel

OTHER

Sponsor Role: collaborator

General Hospital Groeninge

OTHER

Sponsor Role: collaborator

Ziekenhuis Oost-Limburg

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

UZ Brussel

Brussels, , Belgium

Ziekenhuis Oost-Limburg - campus Sint-Jan

Genk, , Belgium

AZ Groeninge

Kortrijk, , Belgium

Ziekenhuis Oost-Limburg - campus Maas en Kempen

Maaseik, , Belgium

Countries

Belgium

Other Identifiers

Z-2025021

Identifier Type: -

Identifier Source: org_study_id