Intracranial AneurysmAIDALOS-IIINCT07123818
AI for Detection of Brain Aneurysm: Low-cost Opportunistic Screening
A study testing AI software in people with Intracranial Aneurysm, run by Ziekenhuis Oost-Limburg at 4 sites in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Intracranial Aneurysm
- What is being tested?
- AI software
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 4 sitesBelgium
- Study dates
- 24 Oct 2025to 31 Dec 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Show all 11Show fewer
- 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.
Who cannot join
- There are no specific exclusion criteria.
Trial locations and contacts
4 sites in 1 country.
Belgium4 sites
UZ Brussel
Brussels, 1090
Ziekenhuis Oost-Limburg - campus Sint-Jan
Genk, 3600
AZ Groeninge
Kortrijk, 8500
Ziekenhuis Oost-Limburg - campus Maas en Kempen
Maaseik, 3680
About this study
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?
Read more
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
- Being tested
- AI software
- Keywords
- Aneurysm, Intracranial, UIA, Unruptured
- Medical subject headings
- Intracranial Aneurysm, Aneurysm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AI softwareDevice
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).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: AI software |
What is being measured
The primary outcome is the main question the study is designed to answer.
Verify the opportunistic screening potential of the AI software for detection of brain UIA on routinely performed brain NECT scans in a prospective setting
Measured: 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.
Measured: 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.
Measured: 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
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.
Measured: 5 years after patient enrolment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2025
- Study start24 Oct 2025
- Primary completion9 Dec 2025
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intracranial AneurysmStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Prospective multicentric interventional study design
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ziekenhuis Oost-Limburg
- Sponsor type
- University, hospital or other
- Collaborators
- Robovision BV, Universitair Ziekenhuis Brussel, General Hospital Groeninge
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07123818
- Sponsor's protocol ID
- Z-2025021
- Acronym
- AIDALOS-III
- Status last verified
- Jan 2026
- First submitted
- 2 Jun 2025
- Last updated
- 12 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- AI for Detection of Brain Aneurysm: Low-cost Opportunistic Screening
- ClinicalTrials.gov ID
- NCT07123818
- Acronym / sponsor ID
- AIDALOS-III / Z-2025021
- Conditions
- Intracranial Aneurysm
- Keywords
- Aneurysm, Intracranial, UIA, Unruptured
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Ziekenhuis Oost-LimburgUniversity, hospital or other
- Collaborators
- Robovision BV, Universitair Ziekenhuis Brussel, General Hospital Groeninge
- Study start
- 24 Oct 2025 (actual)
- Primary completion
- 9 Dec 2025 (actual)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 14 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective multicentric interventional study design
| Arm | Type | Receives |
|---|---|---|
| Brain NECT scans with possible UIA detected by AI software and radiologist | Other | Device: AI softwarePatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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
- a first informed consent form must be signed before brain NECT scans can be transferred to Robovision
Key exclusion criteria (1 listed)
- There are no specific exclusion criteria.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AI softwareAI 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). | Device | Brain NECT scans with possible UIA detected by AI software and radiologist |
Primary outcome
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
3 secondary outcomes
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.
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.
Verify patients' complications by review of the EPD after 5 years
Time frame: 5 years after patient enrolment.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AI software in people with Intracranial Aneurysm, run by Ziekenhuis Oost-Limburg at 4 sites in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 12 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2026.