AI Models for Cerebral Aneurysms Segmentation, Detection and Stability Prediction

NCT06766422 | Recruiting DMC

• 1 other identifier: AI-CARE
• Study Type: observational
• Target: 10,000
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Unruptured Cerebral Aneurysm; Artificial Intelligence (AI); Subarachnoid Hemorrhage, Aneurysmal; Magnetic Resonance Angiography

Keywords

Artificial Intelligence; Cerebral Aneurysms; Magnetic Resonance Angiography; Subarachnoid Hemorrhage

Outcome Measures

Primary Outcomes (2)

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

  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.

  1 month

• Consistency between the artificial intelligence model and radiologists' image interpretations.

  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.

  1 month

Study Arms (4)

Single MRA

The patient has undergone an MRA examination only once.

Multiple MRIs for one patient

The same patient underwent multiple MRAs.

MRA+DSA

The patient underwent both MRA and DSA within three months.

MRA+CTA

The patient underwent both MRA and CTA within three months.

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

There is a preliminary diagnosis or symptoms indicating the presence or potential of a cerebral aneurysm.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai Jiao Tong University Affiliated Sixth People's Hospital: lead

Study Sites (1)

Shanghai Sixth People's Hospital, Shanghai, 200023

Shanghai, China

RECRUITING

MeSH Terms

Conditions

Subarachnoid Hemorrhage; Intracranial Aneurysm

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Yueqi Zhu

CONTACT

+86-21-66301136; zhuyueqi@hotmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 25, 2024
• First Posted: January 9, 2025
• Study Start: January 10, 2025
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2027
• Last Updated: June 3, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)