Lung CancerRADICALNCT06044454
Radiograph Accelerated Detection and Identification of Cancer in the Lung
An observational study of Lung Cancer, run by NHS Greater Glasgow and Clyde at 4 sites in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer
- What is being tested?
- qXR
- How many people
- 60,000 participants
- Where
- 4 sitesUnited Kingdom
- Study dates
- 4 Dec 2023to 30 Nov 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Service deployment within a single health board (NHS Greater Glasgow and Clyde), within the following sectors and hospitals: Clyde Sector * The Royal Alexandra Hospital * Inverclyde Royal Hospital * Vale of Leven Hospital South Sector * Queen Elizabeth University Hospital * New Victoria Hospital * Gartnavel General Hospital * West Glasgow Ambulatory Care Hospital North Sector * Glasgow Royal Infirmary * Stobhill Hospital At each participating site, the investigators will identify all patients referred through the outpatient pathway (including GP-referrals). This will include those with suspected lung cancer referred for CXR.
Who may be able to join
- 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).
Who cannot join
- 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).
Trial locations and contacts
4 sites in 1 country.
United Kingdom4 sites
Glasgow Royal Infirmary (North Sector)
Glasgow
NHS Greater Glasgow and Clyde
Glasgow
Queen Elizabeth University Hosp (South Sector)
Glasgow
The Royal Alexandra Hospital (Clyde Sector)
Paisley
About this study
Official title: RADICAL: A Mixed Methods Study to Assess the Clinical Effectiveness and Acceptability of an Artificial Intelligence Software to Prioritise Chest X-ray (CXR) Interpretation
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.
Read more
The project includes different elements including:
- 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:
- 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
Read the detailed description
A clinical effectiveness study will be conducted in 3 NHS Greater Glasgow and Clyde sectors over a 12-month period.
Sectors will be identified and initiated into the qXR solution with a 30 day implementation period. The order in which sites will receive the qXR intervention will be determined by computer-based randomisation.
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). An economic evaluation will be conducted comparing costs and outcomes with and without the introduction of qXR. The software potentially impacts costs via two mechanisms: the identification of normal can enhance efficiency of CXR reporting; and the identification of USCs can support the prioritisation of CXRs that show signs of lung cancer, accelerating the provision of CT, which leads to faster diagnosis and treatment, and ultimately better outcomes.
Qualitative evaluation: To determine acceptability, staff interviews and patient focus groups will be carried out.
Data will be collected by an experienced qualitative researcher using a semi-structured interview guide, developed based on the key constructs of the Theoretical Framework of Acceptability. All interviews will be conducted via Zoom at a mutually agreed upon date and time and are estimated to last, on average, around 45 minutes.
To capture the NHS service user perspective, the investigators will also conduct three online focus groups with approximately 20 NHS service users.
- Conditions
- Lung Cancer
- Being tested
- qXR
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
qXROther
a software product that uses artificial intelligence to triage, prioritise, and (for tuberculosis only) diagnose based upon identified abnormalities within the CXR.
| Study group | Role | What they receive |
|---|---|---|
| Service deployment | Intervention Chest X-ray received - care team (standard of care) CT scan - care team (standard of care) Receives: Other: qXR |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to 'decision to recommend CT', or to a decision not to undertake CT for CXR acquired with USC (CXR acquired to CXR reported)
Time to 'decision to recommend CT', or to a decision not to undertake CT for CXR acquired with USC (CXR acquired to CXR reported)
Measured: through study completion, an average of 1 year
Secondary outcomes (9)
Time from acquisition to reporting of all CXRs
Time from acquisition to reporting of all CXRs
Measured: through study completion, an average of 1 year
Time to diagnosis of lung cancer
Time to diagnosis of lung cancer
Measured: through study completion, an average of 1 year
Time to treatment initiation lung cancer
Time to treatment initiation lung cancer
Measured: through study completion, an average of 1 year
Number of hospital visits during screening pathway
Number of hospital visits during screening pathway
Measured: through study completion, an average of 1 year
Hospitalisation within 6 and 12 months CXR acquisition
Hospitalisation within 6 and 12 months CXR acquisition
Measured: through study completion, an average of 1 year
Death within 6 and 12 months of CXR acquisition
Death within 6 and 12 months of CXR acquisition
Measured: through study completion, an average of 1 year
Percentage of CXRs not identified by qXR as suspected lung cancer that the radiologist refers for CT for USC
Percentage of CXRs not identified by qXR as suspected lung cancer that the radiologist refers for CT for USC
Measured: through study completion, an average of 1 year
Percentage of non-USC that are referred for CT with subsequent detection of lung cancer
Percentage of non-USC that are referred for CT with subsequent detection of lung cancer
Measured: through study completion, an average of 1 year
Model performance e.g. sensitivity, specificity, positive and negative predictive values.
Model performance e.g. sensitivity, specificity, positive and negative predictive values.
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2023
- Study start4 Dec 2023
- Primary completion30 Nov 2025 (estimated)
- Study completion30 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Enrolment
- 60,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NHS Greater Glasgow and Clyde
- Sponsor type
- University, hospital or other
- Collaborators
- Qure.ai Technologies Pvt. Ltd
- Responsible party
- Sponsor
- Investigators
- David Lowe, Principal investigator, NHS Greater Glasgow and Clyde Board HQ
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06044454
- Sponsor's protocol ID
- INGN23RM028
- Other IDs
- 23/NW/0211
- Acronym
- RADICAL
- Status last verified
- Sep 2025
- First submitted
- 29 Aug 2023
- Last updated
- 19 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Duncan SF, McConnachie A, Blackwood J, Stobo DB, Maclay JD, Wu O, Germeni E, Robert D, Bilgili B, Kumar S, Hall M, Lowe DJ. Radiograph accelerated detection and identification of cancer in the lung (RADICAL): a mixed methods study to assess the clinical effectiveness and acceptability of Qure.ai artificial intelligence software to prioritise chest X-ray (CXR) interpretation. BMJ Open. 2024 Sep 20;14(9):e081062. doi: 10.1136/bmjopen-2023-081062.
PubMed 39306349
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RADICAL: A Mixed Methods Study to Assess the Clinical Effectiveness and Acceptability of an Artificial Intelligence Software to Prioritise Chest X-ray (CXR) Interpretation
- ClinicalTrials.gov ID
- NCT06044454
- Acronym / sponsor ID
- RADICAL / INGN23RM028
- Conditions
- Lung Cancer
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 60,000 participants (estimated)
- Lead sponsor
- NHS Greater Glasgow and ClydeUniversity, hospital or other
- Collaborators
- Qure.ai Technologies Pvt. Ltd
- Study start
- 4 Dec 2023 (actual)
- Primary completion
- 30 Nov 2025 (estimated)
- Study completion
- 30 Nov 2025 (estimated)
- First posted
- 21 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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:
- 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
Detailed description
A clinical effectiveness study will be conducted in 3 NHS Greater Glasgow and Clyde sectors over a 12-month period.
Sectors will be identified and initiated into the qXR solution with a 30 day implementation period. The order in which sites will receive the qXR intervention will be determined by computer-based randomisation.
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). An economic evaluation will be conducted comparing costs and outcomes with and without the introduction of qXR. The software potentially impacts costs via two mechanisms: the identification of normal can enhance efficiency of CXR reporting; and the identification of USCs can support the prioritisation of CXRs that show signs of lung cancer, accelerating the provision of CT, which leads to faster diagnosis and treatment, and ultimately better outcomes.
Qualitative evaluation: To determine acceptability, staff interviews and patient focus groups will be carried out.
Data will be collected by an experienced qualitative researcher using a semi-structured interview guide, developed based on the key constructs of the Theoretical Framework of Acceptability. All interviews will be conducted via Zoom at a mutually agreed upon date and time and are estimated to last, on average, around 45 minutes.
To capture the NHS service user perspective, the investigators will also conduct three online focus groups with approximately 20 NHS service users.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Service deployment | – | Other: qXRIntervention Chest X-ray received - care team (standard of care) CT scan - care team (standard of care) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Service deployment within a single health board (NHS Greater Glasgow and Clyde), within the following sectors and hospitals: Clyde Sector * The Royal Alexandra Hospital * Inverclyde Royal Hospital * Vale of Leven Hospital South Sector * Queen Elizabeth University Hospital * New Victoria Hospital * Gartnavel General Hospital * West Glasgow Ambulatory Care Hospital North Sector * Glasgow Royal Infirmary * Stobhill Hospital At each participating site, the investigators will identify all patients referred through the outpatient pathway (including GP-referrals). This will include those with suspected lung cancer referred for CXR.
Key inclusion criteria (3 listed)
- 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).
Key exclusion criteria (1 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| qXRa software product that uses artificial intelligence to triage, prioritise, and (for tuberculosis only) diagnose based upon identified abnormalities within the CXR. | Other | Service deployment |
Primary outcome
Time to 'decision to recommend CT', or to a decision not to undertake CT for CXR acquired with USC (CXR acquired to CXR reported)
Time frame: through study completion, an average of 1 year
Time to 'decision to recommend CT', or to a decision not to undertake CT for CXR acquired with USC (CXR acquired to CXR reported)
9 secondary outcomes
Time from acquisition to reporting of all CXRs
Time frame: through study completion, an average of 1 year
Time to diagnosis of lung cancer
Time frame: through study completion, an average of 1 year
Time to treatment initiation lung cancer
Time frame: through study completion, an average of 1 year
Number of hospital visits during screening pathway
Time frame: through study completion, an average of 1 year
Hospitalisation within 6 and 12 months CXR acquisition
Time frame: through study completion, an average of 1 year
Death within 6 and 12 months of CXR acquisition
Time frame: through study completion, an average of 1 year
Percentage of CXRs not identified by qXR as suspected lung cancer that the radiologist refers for CT for USC
Time frame: through study completion, an average of 1 year
Percentage of non-USC that are referred for CT with subsequent detection of lung cancer
Time frame: through study completion, an average of 1 year
Model performance e.g. sensitivity, specificity, positive and negative predictive values.
Time frame: through study completion, an average of 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2025.
- Derived from this study: PubMed 39306349Duncan SF, McConnachie A, Blackwood J, Stobo DB, Maclay JD, Wu O, Germeni E, Robert D, Bilgili B, Kumar S, Hall M, Lowe DJ. Radiograph accelerated detection and identification of cancer in the lung (RADICAL): a mixed methods study to assess the clinical effectiveness and acceptability of Qure.ai artificial intelligence software to prioritise chest X-ray (CXR) interpretation. BMJ Open. 2024 Sep 20;14(9):e081062. doi: 10.1136/bmjopen-2023-081062.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Lowe principal investigator
NHS Greater Glasgow and Clyde Board HQ
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Cancer, run by NHS Greater Glasgow and Clyde at 4 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 19 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary 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) (time frame: through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06044454, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2025.