RADICAL: A Mixed Methods Study to Assess the Clinical Effectiveness and Acceptability of an Artificial Intelligence Software to Prioritise Chest X-ray (CXR) Interpretation
Trial ID: NCT06044454
Status: ACTIVE_NOT_RECRUITING
Study type: OBSERVATIONAL
Start date: 2023-12-04
Completion date: 2025-11-30
Sponsor: NHS Greater Glasgow and Clyde
Collaborators: Qure.ai Technologies Pvt. Ltd
Conditions: Lung Cancer
Interventions: qXR
Locations: Glasgow Royal Infirmary (North Sector); NHS Greater Glasgow and Clyde; Queen Elizabeth University Hosp (South Sector); The Royal Alexandra Hospital (Clyde Sector)
Countries: United Kingdom; United Kingdom; United Kingdom; United Kingdom
Enrollment: 60000
Age range: 18 Years - None
Sex: ALL

Summary:
Lung cancer is the most common cause of cancer death in the UK yet compared to Europe it has low survival rates.The NHS aims to find 75% of cancers at an early stage as this can improve the chances of survival.

To support this target, Qure.ai have developed the UK-approved qXR product, which is a software program that automatically analyses chest x-rays using artificial intelligence to identify features associated with lung cancer, indicative of other diagnoses, or that contain no abnormal features ('normal'). qXR is a class IIb medical device that can be used by radiologists to prioritise reporting based upon the presence or absence of these features. This may improve the accuracy and efficiency of reporting these images.

The project includes different elements including:

i) Clinical effectiveness study across 3 sectors within NHS Greater Glasgow and Clyde (NHSGGC).The primary objective is to assess the clinical effectiveness of qXR to prioritise patients that have suspected lung cancer (identified from AI analysis of a chest x-ray) for follow-on CT.

Primary study outcome measure - Time to 'decision to recommend CT', or to a decision not to undertake CT for CXR acquired with USC (CXR acquired to CXR reported).

Secondary objectives include:

i) To assess the potential utility of qXR within the optimised lung cancer pathway in terms of the impact on both patient treatment and radiological workflow.

ii) A technical evaluation utilising retrospective and prospective cohorts. The technical retrospective study will determine the performance of qXR using a sample of 1000 CXR images from all chest x-ray referral sources across all sectors (this differs from the prospective study, which only examines outpatient referred chest x-rays).

iii) A health economic evaluation. Use of per patient healthcare utilisation costs to model cost benefits of qXR, including implementation of supported reporting of normal CXR.

iv) A qualitative evaluation to assess acceptability and barriers to scale-up and implementation

Eligibility criteria:
Inclusion Criteria:

* Unconsented patients ≧ 18 years old with frontal chest radiograph, acquired consecutively during usual care through the outpatient (including GP) referral pathway only, whose radiograph has not already been reported (applies to clinical effectiveness and health economic evaluation studies).
* Unconsented patients ≧ 18 years old with frontal chest radiograph, sampled from images already acquired and reported in the current or previous calendar year (applies to technical evaluation).
* Key stakeholders such as NHS service users, healthcare staff and NHS management (applies to qualitative evaluation).

Exclusion Criteria:

* Patient has requested that they are removed from the study, or has objected to the use of AI in their routine clinical care and this has been subsequently upheld by the health board (applies to clinical effectiveness study, health economic evaluation and technical evaluation).

Outcomes:
Time to 'decision to recommend CT', or to a decision not to undertake CT for CXR acquired with USC (CXR acquired to CXR reported)