Unruptured Cerebral AneurysmAI-CARENCT06766422
AI Models for Cerebral Aneurysms Segmentation, Detection and Stability Prediction
An observational study of Unruptured Cerebral Aneurysm and Artificial Intelligence (AI), run by Shanghai Jiao Tong University Affiliated Sixth People's Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Unruptured Cerebral Aneurysm, Artificial Intelligence (AI), Subarachnoid Hemorrhage, Aneurysmal
- How many people
- 10,000 participants
- Where
- 1 siteChina
- Study dates
- 10 Jan 2025to 30 Jun 2027
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: There is a preliminary diagnosis or symptoms indicating the presence or potential of a cerebral aneurysm.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Shanghai Sixth People's Hospital, Shanghai, 200023
Shanghai
Yueqi Zhu, MD, +86-21-66301136, zhuyueqi@hotmail.com
Yueqi Zhu, MD
About this study
Official title: Artificial Intelligence Applications for Cerebral Aneurysms Segmentation, Detection and Stability Prediction: a Stepwise, Multicenter Study
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
- Medical subject headings
- Subarachnoid Hemorrhage, Intracranial Aneurysm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2025
- Study start10 Jan 2025
- Primary completion30 Jun 2026 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Unruptured Cerebral AneurysmStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 10,000 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Shanghai Jiao Tong University Affiliated Sixth People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yueqi Zhu, Shanghai Jiao Tong University Affiliated Sixth People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06766422
- Sponsor's protocol ID
- AI-CARE
- Acronym
- AI-CARE
- Status last verified
- Dec 2024
- First submitted
- 25 Dec 2024
- Last updated
- 3 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Artificial Intelligence Applications for Cerebral Aneurysms Segmentation, Detection and Stability Prediction: a Stepwise, Multicenter Study
- ClinicalTrials.gov ID
- NCT06766422
- Acronym / sponsor ID
- AI-CARE / AI-CARE
- Conditions
- Unruptured Cerebral Aneurysm, Artificial Intelligence (AI), Subarachnoid Hemorrhage, Aneurysmal, Magnetic Resonance Angiography
- Keywords
- Artificial Intelligence, Cerebral Aneurysms, Magnetic Resonance Angiography, Subarachnoid Hemorrhage
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 10,000 participants (estimated)
- Lead sponsor
- Shanghai Jiao Tong University Affiliated Sixth People's HospitalUniversity, hospital or other
- Study start
- 10 Jan 2025 (actual)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 9 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- There is a preliminary diagnosis or symptoms indicating the presence or potential of a cerebral aneurysm.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Unruptured Cerebral Aneurysm and Artificial Intelligence (AI), run by Shanghai Jiao Tong University Affiliated Sixth People's Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yueqi Zhu (+86-21-66301136, zhuyueqi@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Consistency between the artificial intelligence model and the manually annotated gold standard. (time frame: 1 month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2025.