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

Status: Recruiting
Location: See location...
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
China
Shanghai Sixth People's Hospital, Shanghai, 200023
RECRUITING
Shanghai
Contact Information
Primary
Yueqi Zhu
zhuyueqi@hotmail.com
+86-21-66301136
Time Frame
Start Date: 2025-01-10
Estimated Completion Date: 2027-06-30
Participants
Target number of participants: 10000
Treatments
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.
Related Therapeutic Areas
Sponsors
Leads: Shanghai Jiao Tong University Affiliated Sixth People's Hospital

This content was sourced from clinicaltrials.gov