Blinded randomized test of an AI tool to find brain aneurysms on head CTA

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a multicenter, prospective, double-blind randomized trial enrolling more than 6,450 adults who undergo head CT angiography at 21 hospitals across more than 10 provinces in China. Patients' CTA images are randomized 1:1 to a True-AI–aided diagnostic workflow or a Sham-AI workflow (sham has near-zero sensitivity but similar specificity), with both patients and radiologists blinded to allocation. The primary outcomes are sensitivity and specificity for detecting intracranial aneurysms, and secondary outcomes include detection of other intracranial lesions, interpretive workload, downstream resource use and treatments, 12-month imaging follow-up, patient quality of life, aneurysm-related events, and cost-effectiveness. The trial is designed to measure both diagnostic performance and the short- and long-term impact of integrating AI into routine CTA practice.

Why it matters

Who can join: the full rules

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.

Where it's running

• The First Affiliated Hospital of University of Science and Technology of China
  Hefei, Anhui, China Recruiting
• The First Affiliated Hospital of Wannan Medical College
  Wuhu, Anhui, China Recruiting
• Guizhou Provincial People's Hospital
  Guiyang, Guizhou, China Recruiting
• First Affiliated Hospital of Zhengzhou University
  Zhengzhou, Henan, China Recruiting
• Shiyan People's Hospital
  Shiyan, Hubei, China Recruiting
• Research Institute Of Medical Imaging Jinling Hospital
  Nanjing, Jiangsu, China Recruiting

Study contacts

• Principal investigator: Trial Manager — Jinling Hospital, Affiliated Hospital of Medical School, Nanjing University
• Study coordinator: Longjiang Zhang, MD
• Email: kevinzhlj@163.com
• Phone: +8613405833176

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.