IDEAL Study: Blinded RCT for the Impact of AI Model for Cerebral Aneurysms Detection on Patients' Diagnosis and Outcomes

Jinling Hospital, China

Status: Enrolling

Conditions: Deep Learning; CT Angiography; Intracranial Aneurysm; Double Bind Interaction

Treatments: Device: True-AI-integrated intracranial aneurysms diagnosis strategy; Device: Sham-AI-integrated intracranial aneurysms diagnosis strategy

Study type: Interventional

Funder types: Other

Identifiers

NCT06118840

2022NZKY-015-05

Details and patient eligibility

About

This study (IEDAL study) intends to prospectively enroll more than 6450 patients who will undergo head CT angiography (CTA) scanning in the outpatient clinic. It will be carried out in 21 hospitals in more than 10 provinces in China. The patient's head CTA images will be randomly assigned to the True-AI and Sham-AI group with a ratio of 1:1, and the patients and radiologists are unaware of the allocation. The primary outcomes are sensitivity and specificity of detecting intracranial aneurysms. The secondary outcomes focus on the prognosis and outcomes of the patients.

Full description

A multicenter, prospective, double-blind, randomized controlled trial will be conducted (IDEAL study). Patients who are scheduled to undergo cranial CT angiography (CTA) scanning will be randomly divided into two groups with a ratio of 1:1, one of the group will be assigned to True-AI aided intracranial aneurysms diagnosis strategy (True-AI group) and the other will be assigned to Sham-AI aided intracranial aneurysms diagnosis strategy (Sham-AI group, which has a sensitivity close to 0% and a similar specificity to True-AI). The primary outcomes are diagnostic sensitivity and specificity of detecting aneurysms. Secondary endpoints include other diagnostic performance indexes for intracranial aneurysms; diagnostic performances for other intracranial lesions for intracranial arterial stenosis, occlusion, and intracranial tumors; detection rates of intracranial lesions according to Radiology Reports; workload of head CTA interpretation; resource use; treatment-related indexes during patient follow-up (e.g. clinical follow-up, hospitalization, rate of patients undergoing DSA); life quality; outcomes of aneurysm-related events; repeat head CTA or MRA at 12-month follow; cost-effectiveness analysis between intervention and control arm to evaluate the short- and longterm influence of AI system to the routine practice and patients' prognosis and outcomes.

Enrollment: 6,450 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Adult inpatients and outpatients who are scheduled for head CTA scanning.

Exclusion criteria

• Age under 18 years.
• Patients with contraindications to CTA.
• Modified Rankin Scale (mRS) score > 3.
• Refuse to sign informed consent.
• Participation in other clinical studies of intracranial aneurysms.
• Patients with failed head CTA scanning or incomplete image data, or poor image quality.

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

6,450 participants in 2 patient groups

True-AI-integrated intracranial aneurysms diagnosis strategy

Experimental group

Description:

For patients who underwent head CTA and assigned to True-AI group, they will be diagnosed by a radiologist who are aided by the True-AI-integrated intracranial aneurysms diagnosis strategy.

Treatment:

Device: True-AI-integrated intracranial aneurysms diagnosis strategy

Sham-AI-integrated intracranial aneurysms diagnosis strategy

Sham Comparator group

Description:

For patients who underwent head CTA and assigned to Sham-AI group, they will be diagnosed by a radiologist who are aided by the Sham-AI-integrated intracranial aneurysms diagnosis strategy. To mimic the True-AI, the Sham-AI had a sensitivity close to 0% and a similar specificity to the True-AI.

Treatment:

Device: Sham-AI-integrated intracranial aneurysms diagnosis strategy