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NCT Number: NCT06018545

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

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.

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Key information

Conditions

Intracranial Hemorrhages Acute Ischemic Stroke Brain Diseases Brain Edema Brain Infarction Brain Injuries Brain Ischemia Cardiovascular Diseases Central Nervous System Diseases Cerebral Edema Cerebral Infarction Cerebral Injury Cerebrovascular Disorders Craniocerebral Trauma Hemorrhage Hydrocephalus Infarction Ischemia Ischemic Stroke Necrosis Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Stroke Trauma, Nervous System Vascular Diseases Wounds and Injuries

Sex eligibility

All sexes

Study type

Observational

Primary location

Guy's & St Thomas NHS Foundation Trust, London, United Kingdom

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Radiologists/Radiographers/ED clinicians who review CT head scans as part of their clinical practice

Exclusion criteria

  • Neuroradiologists.
  • Non-radiologist groups: Clinicians with previous formal postgraduate CT reporting training
  • Emergency Medicine group: Clinicians with previous career in radiology/neurosurgery to registrar level

Treatment and study plan

Ground truthing

Other

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.

Reading

Other

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.

Primary outcomes

  1. Reader performance: Sensitivity, specificity, comparative between with and without AI assistance.

    Time frame: During 6 weeks, which is the period for reading or reviewing the cases/scans.

    Reader performance will be evaluated as sensitivity, specificity, with and without AI assistance.

  2. Reader performance: Positive and negative predictive value, comparative between with and without AI assistance.

    Time frame: During 6 weeks, which is the period for reading or reviewing the cases/scans.

    Reader performance will be evaluated as Positive Predictive Value (PPV) and negative predictive value (NPV), with and without AI assistance.

  3. Reader performance: Area Under Receiver Operating Characteristic Curve (AUROC), comparative between with and without AI assistance.

    Time frame: During 6 weeks, which is the period for reading or reviewing the cases/scans.

    Reader performance will be evaluated as Area Under Receiver Operating Characteristic Curve (AUROC), with and without AI assistance.

  4. Reader speed: Mean time taken to review a scan, with versus without AI assistance.

    Time frame: During 6 weeks, which is the period for reading or reviewing the cases/scans.

    Reader speed will be evaluated as the man time taken to review a scan, using time unite of seconds.

  5. Reader confidence: Self-reported diagnostic confidence on a 10 point visual analogue scale, with vs without AI assistance.

    Time frame: During 6 weeks, which is the period for reading or reviewing the cases/scans.

    On the reading platform (RAIQC), one of the questions asks the level of confidence that the participant has in their diagnostic opinion. The question offers a scale of 1 to 10, where 1 is not confident, and 10 is highly confident.

  6. qER (AI algorithm) performance: Sensitivity and specificity

    Time frame: During 6 weeks, which is the period for reading or reviewing the cases/scans.

    qER performance will be evaluated as sensitivity, specificity.

  7. qER (AI algorithm) performance: Positive and negative predictive value.

    Time frame: During 6 weeks, which is the period for reading or reviewing the cases/scans.

    qER performance will be evaluated as Positive Predictive Value (PPV) and negative predictive value (NPV).

  8. qER (AI algorithm) performance: Area Under Receiver Operating Characteristic Curve (AUROC).

    Time frame: During 6 weeks, which is the period for reading or reviewing the cases/scans.

    qER performance will be evaluated as Area Under Receiver Operating Characteristic Curve (AUROC)

Sponsors and collaborators

Lead sponsor

Oxford University Hospitals NHS Trust

Other

Registry information

Official study title

AI Assisted Reader Evaluation in Acute CT Head Interpretation

Acronym: AI-REACT

Important dates

Study start
2023
Primary completion
2023
Study completion
2025
First posted
Aug 30, 2023
Registry last updated
Nov 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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