Actively Recruiting
Artificial Intelligence Applications for Cerebral Aneurysms Segmentation, Detection and Stability Prediction: a Stepwise, Multicenter Study
Led by Shanghai Jiao Tong University Affiliated Sixth People's Hospital · Updated on 2025-06-03
10000
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Aneurysmal subarachnoid hemorrhage (SAH) is a serious condition with a high mortality rate, and early diagnosis before rupture is critical to improving outcomes. With advances in non-invasive cerebrovascular imaging like CTA and MRA, more unruptured intracranial aneurysms (UIAs) are being detected. This study evaluates an artificial intelligence (AI) algorithm designed to automatically identify intracranial aneurysms from imaging data, aiming to improve diagnostic accuracy and help identify aneurysms at high risk of rupture to avoid unnecessary treatments and related harms. The study is a prospective, multicenter, registry observational study. It involves analyzing imaging data from patients undergoing different combinations of vascular imaging tests such as single or multiple MRAs, MRA combined with DSA, or MRA combined with CTA within three months. The AI software will be assessed by comparing its aneurysm detection and segmentation with manually annotated images and radiologists' interpretations. Participants will undergo standardized non-invasive imaging follow-up over time. Researchers will collect imaging profiles and correlate them with aneurysm outcomes like growth or rupture. They will assess consistency between the AI model and expert annotations within one month. This approach aims to improve diagnosis and risk prediction for unruptured cerebral aneurysms, helping guide patient care based on imaging features and long-term follow-up data.
CONDITIONS
Brief Title
AI Models for Cerebral Aneurysms Segmentation, Detection and Stability Prediction
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Preliminary diagnosis or symptoms indicating presence or potential presence of a cerebral aneurysm
- Undergoing a non-contrast head MRA or contrast-enhanced head/neck CTA
- Able and willing to sign an informed consent form
You will not qualify if you...
- Other intracranial vascular diseases such as moyamoya disease, arteriovenous malformations, arteriovenous fistulas, arterial occlusions, and arterial dissections
- History of intracranial arterial interventions including stent placement or partial aneurysm coil treatment
- Severe allergy to contrast agents or absolute contraindications to iodine-based contrast agents (excluded from CTA sub-study only)
- Renal insufficiency with elevated serum creatinine above twice the upper normal limit (excluded from CTA sub-study only)
- MRI contraindications such as pacemakers or claustrophobia (excluded from CTA sub-study only)
- Diseases or conditions affecting quality of CTA/MRA images
- Inability to complete the study due to psychiatric disorders, cognitive, or emotional disturbances (excluded from CTA sub-study only)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Within 3 months
Participants undergo imaging examinations including MRA, DSA, or CTA according to their assigned group to collect diagnostic data.
1 to multiple visits depending on imaging procedures
Duration - 1 month
Participants' imaging data are observed and analyzed over time to assess the consistency of AI models with manual and radiologist interpretations.
No additional visits required
Trial Site Locations
Total: 1 location
1
Shanghai Sixth People's Hospital, Shanghai, 200023
Shanghai, China
Actively Recruiting
Research Team
Y
Yueqi Zhu
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
4
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