ANEURYSM@RISK: Automatic Intracranial Aneurysm Quantification and Feature Learning Modelling to Optimize Intracranial Aneurysm Rupture Prediction

NCT07111975 | Active Not Recruiting

• 1 other identifier: 23U-0036_AWARE
• Study Type: observational
• Target: 3,800
• Locations: 1 country
• Sites: 1

Brief Summary

ANEURYSM@RISK is an observational study aiming to develop and validate an artificial intelligence (AI)-based prediction model for the growth and rupture of intracranial aneurysms (IAs). By applying automated 3D segmentation and morphological quantification of IAs from MR angiography (MRA) scans, the model is intended to provide clinicians with objective and reproducible risk estimates of aneurysm instability. The study utilizes retrospective imaging data from multiple European centers, including UMC Utrecht, AP-HP Paris, and University Medical Center Hamburg-Eppendorf (UKE). A clinical vignette study will evaluate the model's clinical utility and user experience among interventional radiologists. This study is exempt from medical ethics review (non-WMO in the Netherlands), as it involves only existing, anonymized data and imposes no additional burden on patients.

Conditions

Intracranial Aneurysms; Unruptured Intracranial Aneurysm; Subarachnoid Hemorrhage (SAH) From Ruptured Aneurysm

Keywords

Artificial Intelligence; Intracranial Aneurysm; Brain Aneurysm; Unruptured Intracranial Aneurysm; MR Angiography; 3D Segmentation; Rupture/Growth Risk Prediction; Subarachnoid Hemorrhage; Clinical Decision Support; SHERPA; UMC Utrecht; Morphology; Shape

Outcome Measures

Primary Outcomes (1)

• Discriminative performance of AI model for aneurysm instability prediction

  Model performance measured by C-statistic (AUC) with a target threshold of ≥ 0.80. Instability is defined as aneurysm growth and/or rupture during follow-up.

  At time of model validation; Up to 36 months from study start

Secondary Outcomes (5)

• Sensitivity and specificity of AI model

  At time of model validation; Up to 36 months from study start

• Reduction in inter- and intra-observer variability

  During vignette study in clinical setting; During final 6 months of study

• Clinician adherence to AI suggestions

  During vignette study; During final 6 months of study

• Reduction in clinical decision-making time

  During vignette study; During final 6 months of study

• User satisfaction with AI tool

  Immediately after using the AI tool in vignette study; During final 6 months of study

Study Arms (2)

Stable Intracranial Aneurysm Group

Participants with unruptured intracranial aneurysms (UIAs) that remained stable over time, showing no morphological growth or rupture during follow-up. Data are sourced from UMC Utrecht, UKE Hamburg, and AP-HP Paris.

Unstable Intracranial Aneurysm Group

Participants with intracranial aneurysms (IAs) that demonstrated instability over time, defined as morphological growth and/or rupture during follow-up. Data are sourced from UMC Utrecht, UKE Hamburg, and AP-HP Paris.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adults with diagnosed unruptured intracranial aneurysms (UIAs) identified through MR angiography imaging, with follow-up records, from three European academic hospitals. All data are retrospective and anonymized.

You may qualify if:

• Available MR angiography (MRA) scans of the Circle of Willis
• Presence of at least one intracranial aneurysm (IA)
• Availability of follow-up imaging or clinical records indicating stability, growth, or rupture

You may not qualify if:

• Imaging of insufficient quality for segmentation or analysis
• Lack of follow-up data

Sponsors & Collaborators

• UMC Utrecht: lead
• AP-HP (Assistance Publique - Hôpitaux de Paris), FRANCE : Hôpital Pitié Salpêtrière, Hôpital Bichat: collaborator
• University Medical Center Hamburg-Eppendorf (UKE): collaborator
• Philips Medical Systems: collaborator

Study Sites (1)

University Medical Center (UMC) Utrecht

Utrecht, 3584 CX, Netherlands

Location

Related Links

• SHERPA: Smart Human-centred Effortless support for Professional clinical Applications
• SHERPA: Smart Human-centred Effortless support for Professional clinical Applications

MeSH Terms

Conditions

Intracranial Aneurysm; Subarachnoid Hemorrhage; Rupture

Condition Hierarchy (Ancestors)

Intracranial Arterial Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Aneurysm; Vascular Diseases; Cardiovascular Diseases; Intracranial Hemorrhages; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Wounds and Injuries

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD Candidate, Department of Radiology/Neurology

Study Record Dates

• First Submitted: July 28, 2025
• First Posted: August 8, 2025
• Study Start: January 1, 2025
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: August 8, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: The individual participant data (IPD) and supporting documentation will be available after the publication of the main study results. The end date for availability has not yet been determined.
• Access Criteria: Only qualified academic researchers may request access for non-commercial purposes. Requests must include a description of the intended use and can be directed to: p.j.groenheide@umcutrecht.nl.

Locations

NL (1)