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Prospective clinical evaluation of artificial intelligence in radiology

Systematic Assessment for the Medical Utility of Radiology Artificial Intelligence – Prospective Evaluation

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN14908789
Enrollment
45000
Registered
2026-01-19
Start date
2025-10-28
Completion date
Unknown
Last updated
2026-03-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients undergoing medical imaging as part of routine clinical care Other

Interventions

In each sub-study a CE-marked AI tool will be deployed. Clinicians will be able to view AI outputs in addition to standard results to aid in diagnosis when reviewing medical diagnostic tests. The SA
however they will be offered an option to opt-out and have their data removed from the analysis. 2. Patients who have completed the national data opt-out will also be excluded from data analysis. N

Sponsors

Oxford University Hospitals NHS Trust
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. NHS staff who are interacting with the AI tool as part of their standard clinical practice 2. Patients whose medical images, collected as part of standard care, are eligible for analysis using AI

Exclusion criteria

Exclusion criteria: Patients: 1. Those who choose to opt out or have completed the national data opt out NHS Staff: 1. Those not directly involved in the patient care pathway 2. Those using AI for non-clinical purposes, such as research

Design outcomes

Primary

MeasureTime frame
The diagnostic accuracy of the AI algorithm alone in comparison to the clinical reference standard radiologist report: the sensitivity, specificity, accuracy and AUROC of the AI tool in comparison to the clinical reference standard of radiologist's report. Timepoint: dependent on the specific sub-study.

Secondary

MeasureTime frame
1. The technical performance of the AI tool within existing clinical workflows. The number of medical images or tests rejected or not processed by the AI algorithm that fall under the intended use of the AI algorithm, and the reasons for this. Timepoint: dependent on the specific sub-study. 2. The impact on clinical services: length of stay, referral rates, and other relevant NHS encounters or parameters dependent on the sub-study in the AI on period compared to the AI off period. Timepoint: outcomes will be compared during AI tool on periods versus AI tool off periods. 3. NHS staff and patient perspective of the use of AI: questionnaires assessing patient-related outcome measures and feedback from staff. Timepoint: dependent on the specific sub-study.

Countries

England, United Kingdom

Contacts

Public ContactAlex Novak
alex.novak@ouh.nhs.uk+44 (0)1865 231550

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 14, 2026