NCT06018545

AI Assisted Reader Evaluation in Acute Computed Tomography (CT) Head Interpretation

AI Assisted Reader Evaluation in Acute CT Head Interpretation

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 33 (actual)
• Sponsor: Oxford University Hospitals NHS Trust · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Accepted

Summary

This study has been added as a sub study to the Simulation Training for Emergency Department Imaging 2 study (ClinicalTrials.gov ID NCT05427838). The purpose of the study is to assess the impact of an Artificial Intelligence (AI) tool called qER 2.0 EU on the performance of readers, including general radiologists, emergency medicine clinicians, and radiographers, in interpreting non-contrast CT head scans. The study aims to evaluate the changes in accuracy, review time, and diagnostic confidence when using the AI tool. It also seeks to provide evidence on the diagnostic performance of the AI tool and its potential to improve efficiency and patient care in the context of the National Health Service (NHS). The study will use a dataset of 150 CT head scans, including both control cases and abnormal cases with specific abnormalities. The results of this study will inform larger follow-up studies in real-life Emergency Department (ED) settings.

Conditions

• Intracranial Hemorrhages
• Acute Ischemic Stroke
• Hydrocephalus
• Cerebral Infarction
• Cerebral Edema
• Cerebral Injury

Interventions

Type	Name	Description
OTHER	Ground truthing	Two Consultant neuroradiologists will independently review the images to establish the 'ground truth' findings on the CT scans which will be used as the reference standard. In the case of disagreement, a third senior neuroradiologist's opinion will be sought for arbitration.
OTHER	Reading	All 30 readers will review all 150 cases, in each of two study phases. The readers will provide their opinion on the presence or absence of some acute abnormalities, including intracranial haemorrhage, infarct, midline shift and fracture. They will provide a confidence in their diagnosis (10-point visual analogue scale), and a single click point to mark the location of each abnormality that they consider as being present. The time taken for each scan will be automatically recorded.

Timeline

• Start date: 2023-06-01
• Primary completion: 2023-09-01
• Completion: 2025-06-01
• First posted: 2023-08-30
• Last updated: 2025-11-24

Locations

4 sites across 1 country: United Kingdom