NCT07111975|Active Not Recruiting
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Sponsor study identifier
observational
3,800
1 country
1
Study Start
January 1, 2025
Actual (reported)Primary Completion
June 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
December 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 1, 2025
Actual (reported)July 28, 2025
Actual (reported)August 8, 2025
Actual (reported)June 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
December 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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
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
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.
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.
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.
University Medical Center (UMC) Utrecht
Utrecht, 3584 CX, Netherlands
First Submitted
July 28, 2025
First Posted
August 8, 2025
Study Start
January 1, 2025
Actual (reported)Primary Completion
June 2028
EstimatedCompare the Safety and Effectiveness of Two Different Kinds of Stent System in Intracranial Aneurysms
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
Contact the study team to confirm eligibility.
Planned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
December 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
August 8, 2025
Record last verified: 2025-08
De-identified participant-level data derived from imaging, including intracranial aneurysm morphological measurements and risk predictions, will be shared upon reasonable request from qualified investigators.
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Source: ClinicalTrials.gov.
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