What is this study trying to find out about unruptured cerebral aneurysms?

This study is evaluating an artificial intelligence algorithm to automatically identify and analyze unruptured cerebral aneurysms using non-invasive imaging. Researchers aim to improve aneurysm diagnosis accuracy and predict which aneurysms may grow or rupture. The study is sponsored by Shanghai Jiao Tong University Affiliated Sixth People's Hospital and involves multiple centers.

Who may be eligible for this unruptured cerebral aneurysm clinical trial?

Adults aged 18 years and older with a preliminary diagnosis or symptoms suggesting a cerebral aneurysm may be eligible. Participants must be able to undergo specific imaging tests like MRA or CTA and provide informed consent. People with certain vascular diseases or previous intracranial interventions may be excluded. Please review eligibility criteria for more details.

Is there any cost to participate in this unruptured cerebral aneurysm clinical trial?

Study-related care, including imaging and all trial visits, is provided at no cost. However, personal travel and related expenses may vary and are not guaranteed to be covered. Participants should plan accordingly for any costs not included in the study.

Actively Recruiting

Age: 18Years +

All Genders

ID06766422

Study of AI Software for Detecting and Predicting Stability of Unruptured Cerebral Aneurysms Using Non-Invasive Imaging

Led by Shanghai Jiao Tong University Affiliated Sixth People's Hospital · Updated on 2025-06-03

10000

Participants Needed

Research Sites

52 weeks

Total Duration

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

Age: 18Years +

All Genders

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)

Research Team

Yueqi Zhu

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