NCT06766422 AI Models for Cerebral Aneurysms Segmentation, Detection and Stability Prediction
| NCT ID | NCT06766422 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Shanghai Jiao Tong University Affiliated Sixth People's Hospital |
| Condition | Unruptured Cerebral Aneurysm |
| Study Type | OBSERVATIONAL |
| Enrollment | 10,000 participants |
| Start Date | 2025-01-10 |
| Primary Completion | 2026-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 10,000 participants in total. It began in 2025-01-10 with a primary completion date of 2026-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
Inclusion Criteria: 1. Age ≥ 18 years; 2. Preliminary diagnosis or symptoms indicating the presence or potential presence of a cerebral aneurysm; 3. Undergoing a non-contrast head MRA or contrast-enhanced head/neck CTA; 4. The patient or their legal representative is able and willing to sign an informed consent form. Exclusion Criteria: 1. Other intracranial vascular diseases: moyamoya disease, arteriovenous malformations, arteriovenous fistulas, arterial occlusions, and arterial dissections; 2. History of intracranial arterial interventions: stent placement, partial aneurysm coil treatment, etc.; 3. Severe allergy to contrast agents or absolute contraindications to iodine-based contrast agents; 4. Renal insufficiency with elevated serum creatinine (greater than twice the upper normal limit); 5. MRI contraindications: pacemakers, claustrophobia, etc.; 6. Diseases or conditions that affect the quality of CTA/MRA images; 7. 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06766422 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Unruptured Cerebral Aneurysm. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06766422 currently recruiting?
Yes, NCT06766422 is actively recruiting participants. Contact the research team at zhuyueqi@hotmail.com for enrollment information.
Where is the NCT06766422 trial being conducted?
This trial is being conducted at Shanghai, China.
Who is sponsoring the NCT06766422 clinical trial?
NCT06766422 is sponsored by Shanghai Jiao Tong University Affiliated Sixth People's Hospital. The trial plans to enroll 10,000 participants.