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NCT Number: NCT07123818

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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UZ Brussel, Brussels, Belgium

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Exclusion criteria

  • There are no specific exclusion criteria.

Treatment and study plan

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).

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

    Time frame: an average of 1 month after subject enrolment

Secondary outcomes

  1. 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.

    Time frame: Through study completion, an average of 5 years.

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

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

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

    Time frame: 5 years after patient enrolment.

    Patient outcomes measured 5 years after end of enrolment (Q4 2030) including whether or not the patient received complications related to the (non-)treated brain aneurysm, died, and/or whether the aneurysm has ruptured. Complications of ruptured brain aneurysms and subsequent subarachnoid hemorraghe can include, but are not limited to, cerebral vasospasm, hydrocephalus, hyponatremia, seizures, stroke, (permanent) brain damage, coma, and/or death.

Sponsors and collaborators

Lead sponsor

Ziekenhuis Oost-Limburg

Other

Collaborators

  • General Hospital Groeninge
  • Robovision BV
  • Universitair Ziekenhuis Brussel

Registry information

Acronym: AIDALOS-III

Important dates

Study start
2025
Primary completion
2025
Study completion
2030
First posted
Aug 14, 2025
Registry last updated
Jan 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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