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

NCT07123818 | Active Not Recruiting

• 1 other identifier: Z-2025021
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 4

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

Keywords

Aneurysm; Intracranial; UIA; Unruptured

Outcome Measures

Primary Outcomes (1)

• Verify the opportunistic screening potential of the AI software for detection of brain UIA on routinely performed brain NECT scans in a prospective setting

  an average of 1 month after subject enrolment

Secondary Outcomes (3)

• 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 5 years.

• Measure the health-related quality of life of patients by completion of the EQ-5D-5L questionnaire.

  From start patient recruitment until 1 month after last patient signed ICF. Questionnaire to be completed 1 months after signing ICF.

• Verify patients' complications by review of the EPD after 5 years

  5 years after patient enrolment.

Study Arms (1)

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

OTHER

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.

Device: AI software

Interventions

AI software 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).

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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.

Sponsors & Collaborators

• Ziekenhuis Oost-Limburg: lead
• Robovision BV: collaborator
• Universitair Ziekenhuis Brussel: collaborator
• General Hospital Groeninge: collaborator

Study Sites (4)

UZ Brussel

Brussels, 1090, Belgium

Location

Ziekenhuis Oost-Limburg - campus Sint-Jan

Genk, 3600, Belgium

Location

AZ Groeninge

Kortrijk, 8500, Belgium

Location

Ziekenhuis Oost-Limburg - campus Maas en Kempen

Maaseik, 3680, Belgium

Location

MeSH Terms

Conditions

Intracranial Aneurysm; Aneurysm

Condition Hierarchy (Ancestors)

Intracranial Arterial Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Prospective multicentric interventional study design

Study Record Dates

• First Submitted: June 2, 2025
• First Posted: August 14, 2025
• Study Start: October 24, 2025
• Primary Completion: December 9, 2025
• Study Completion (Estimated): December 31, 2030
• Last Updated: January 12, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

BE (4)