AI Models for Cerebral Aneurysms Segmentation, Detection and Stability Prediction

Aneurysmal subarachnoid hemorrhage (SAH) is one of the critical diseases that severely threaten human health, with a clinical mortality rate reaching as high as 30%. Early diagnosis and intervention before rupture are considered key to improving the prognosis of aneurysmal SAH. With the widespread clinical application of non-invasive cerebrovascular imaging techniques, such as CTA and MRA, the detection rate of unruptured intracranial aneurysms (UIAs) has significantly increased. However, addressing the growing demand for clinical cerebrovascular imaging diagnostics raises the challenge of improving diagnostic accuracy while alleviating the workload of diagnostic physicians. Furthermore, considering that not all detected UIAs will rupture, it is crucial to accurately identify high-risk aneurysms prone to rupture to avoid unnecessary overtreatment, which could lead to significant socioeconomic burdens and iatrogenic harm to patients.To meet this clinical need, researchers have developed an artificial intelligence (AI) algorithm to create software capable of automatically identifying intracranial aneurysms based on non-invasive vascular imaging data, enabling accurate diagnosis of aneurysms. To evaluate the clinical utility of this AI algorithm, a prospective, multicenter, registry study was proposed. Through long-term standardized and uniform non-invasive imaging follow-up, individualized imaging analysis profiles will be established. By correlating these profiles with aneurysm outcome events (growth or rupture), imaging features capable of accurately predicting aneurysm growth and rupture will be identified and analyzed. This approach is expected to enhance the accuracy of UIA diagnosis and enable risk stratification for unruptured intracranial aneurysms through the utilization of relevant data.

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Key information

Conditions

Unruptured Cerebral Aneurysm Aneurysm Artificial Intelligence (AI) Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Hemorrhage Intracranial Aneurysm Intracranial Arterial Diseases Intracranial Hemorrhages Magnetic Resonance Angiography Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Subarachnoid Hemorrhage Subarachnoid Hemorrhage, Aneurysmal Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Shanghai Sixth People's Hospital, Shanghai, 200023

Shanghai, China

Location status: Recruiting

Location contact

Yueqi Zhu, MD

CONTACT

[email protected]

+86-21-66301136

Yueqi Zhu, MD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Age ≥ 18 years;
Preliminary diagnosis or symptoms indicating the presence or potential presence of a cerebral aneurysm;
Undergoing a non-contrast head MRA or contrast-enhanced head/neck CTA;
The patient or their legal representative is able and willing to sign an informed consent form.

Exclusion criteria

Other intracranial vascular diseases: moyamoya disease, arteriovenous malformations, arteriovenous fistulas, arterial occlusions, and arterial dissections;
History of intracranial arterial interventions: stent placement, partial aneurysm coil treatment, etc.;
Severe allergy to contrast agents or absolute contraindications to iodine-based contrast agents;
Renal insufficiency with elevated serum creatinine (greater than twice the upper normal limit);
MRI contraindications: pacemakers, claustrophobia, etc.;
Diseases or conditions that affect the quality of CTA/MRA images;
Inability to complete the study due to psychiatric disorders, cognitive, or emotional disturbances.

Note: The CTA sub-study does not include exclusion criterion 5; the MRA sub-study does not include exclusion criteria 3 and 4.

Treatment and study plan

Primary outcomes

Consistency between the artificial intelligence model and the manually annotated gold standard.

Time frame: 1 month

Consistency between the artificial intelligence model and the manually annotated gold standard.Intracranial aneurysms appear as saccular (most common), fusiform, or irregular localized vascular dilations on MRA 3D TOF（Time-of-Flight）.Aneurysms are classified into four main categories based on their diameter: small aneurysms, generally less than five millimeters; small aneurysms, with diameters ranging from 0.5 centimeters to 1.5 centimeters; large aneurysms, typically between 1.5 and 2.5 centimeters; and giant aneurysms, which exceed 2.5 centimeters.
Consistency between the artificial intelligence model and radiologists' image interpretations.

Time frame: 1 month

Consistency between the artificial intelligence model and radiologists' image interpretations.Intracranial aneurysms appear as saccular (most common), fusiform, or irregular localized vascular dilations on MRA 3D TOF（Time-of-Flight）.Aneurysms are classified into four main categories based on their diameter: small aneurysms, generally less than five millimeters; small aneurysms, with diameters ranging from 0.5 centimeters to 1.5 centimeters; large aneurysms, typically between 1.5 and 2.5 centimeters; and giant aneurysms, which exceed 2.5 centimeters.

Study contacts

Contact information is provided by the study sponsor or research team.

Yueqi Zhu

CONTACT

[email protected]

+86-21-66301136

Sponsors and collaborators

Lead sponsor

Shanghai Jiao Tong University Affiliated Sixth People's Hospital

Other

Registry information

Official study title

Artificial Intelligence Applications for Cerebral Aneurysms Segmentation, Detection and Stability Prediction: a Stepwise, Multicenter Study

Acronym: AI-CARE

Important dates

Study start: 2025
Primary completion: 2026
Study completion: 2027
First posted: Jan 9, 2025
Registry last updated: Jun 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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