Actively Recruiting
Led by Jinling Hospital, China · Updated on 2025-10-07
6450
Participants Needed
21
Research Sites
21 weeks
Total Duration
Researchers are conducting the IDEAL study, a large, multicenter, prospective, double-blind randomized controlled trial, to evaluate the impact of an artificial intelligence (AI) model on diagnosing intracranial aneurysms using head CT angiography (CTA). The study aims to compare the diagnostic sensitivity and specificity of this AI-assisted approach against a sham AI method, while also assessing patient prognosis and various clinical outcomes. Over 6450 patients scheduled for head CTA will be enrolled across 21 hospitals in China. Participants will be randomly assigned to one of two groups: the True-AI group, where radiologists use a deep-learning AI model with high sensitivity to assist in diagnosing intracranial aneurysms, and the Sham-AI group, where radiologists use a similar AI model with very low sensitivity but comparable specificity. Both groups will undergo their usual head CTA scans and diagnoses. The study includes a 12-month follow-up to monitor repeat imaging, clinical follow-up, treatment, and patient outcomes. During the study, patients will have their head CTA images interpreted with either the True-AI or Sham-AI assistance, without knowledge of group assignment by patients or radiologists. Researchers will assess diagnostic accuracy, detection rates of intracranial lesions, workload of CTA interpretation, resource use, hospitalization rates, quality of life measures, functional outcomes, and safety indicators at 3, 6, and 12 months. The primary outcomes focus on diagnostic sensitivity and specificity at 6 months, with secondary outcomes covering broader clinical and patient-centered measures over the follow-up period.
CONDITIONS
IDEAL Study: Blinded RCT for the Impact of AI Model for Cerebral Aneurysms Detection on Patients' Diagnosis and Outcomes
You may qualify if you...
You will not qualify if you...
Complete this quick 3-step screening to check your eligibility
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single procedure at baseline
Participants undergo head CT angiography (CTA) scanning and are diagnosed by a radiologist aided by either the True-AI or Sham-AI intracranial aneurysms diagnosis strategy.
1 visit (in-person)
Duration - Up to 12 months
Participants are monitored for diagnostic performance outcomes, resource use, clinical follow-up, treatment-related outcomes, and quality of life over 12 months after the initial diagnosis.
Follow-up visits at 3 months and 12 months
Total: 21 locations
1
The First Affiliated Hospital of University of Science and Technology of China
Hefei, Anhui, China
Actively Recruiting
2
The First Affiliated Hospital of Wannan Medical College
Wuhu, Anhui, China
Actively Recruiting
3
Guizhou Provincial People's Hospital
Guiyang, Guizhou, China
Actively Recruiting
4
First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
Actively Recruiting
5
Shiyan People's Hospital
Shiyan, Hubei, China
Actively Recruiting
6
Research Institute Of Medical Imaging Jinling Hospital
Nanjing, Jiangsu, China, 210018
Actively Recruiting
7
Affiliated Hospital of Xuzhou Medical University
Xuzhou, Jiangsu, China
Actively Recruiting
8
The First Hospital of Jilin University
Changchun, Jilin, China
Actively Recruiting
9
Shandong Provincial Hospital Affiliated to Shandong First Medical University
Jinan, Shandong, China
Actively Recruiting
10
Yidu Central Hospital Affiliated to Shandong Second Medical University
Weifang, Shandong, China
Actively Recruiting
11
The First Affiliated Hospital of Kunming Medical University
Kunming, Yunnan, China
Actively Recruiting
12
Hainan General Hospital
Haikou, China
Actively Recruiting
13
The First People's Hospital of Kashgar Region
Kashgar, China
Actively Recruiting
14
University Second Hospital
Lanzhou, China
Actively Recruiting
15
First People's Hospital of Lianyungang
Lianyungang, China
Actively Recruiting
16
Ma'anshan People's Hospital
Ma’anshan, China
Actively Recruiting
17
BenQ Medical Center, Affiliated BenQ Hospital of Medical School, Nanjing Medical University
Nanjing, China
Actively Recruiting
18
Long Gang Central Hospital of Shenzhen
Shenzhen, China
Actively Recruiting
19
The Affiliated Suqian First Hospital of Nanjing Medical University
Suqian, China
Actively Recruiting
20
Tianjin Medical University General Hospital
Tianjin, China
Actively Recruiting
21
General Hospital of Ningxia Medical University
Yinchuan, China
Actively Recruiting
L
Longjiang Zhang, MD
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
DIAGNOSTIC
Number of Arms
2
Have more questions? Get in touch with our team for quick support
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here
Zhao Shi, Bin Hu, Mengjie Lu...
https://pubmed.ncbi.nlm.nih.gov/38835091