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Pulmonary Nodules, SolitaryAID-CXRNCT06075836

AI Assisted Detection of Chest X-Rays

An observational study of Pulmonary Nodules, Solitary and Pulmonary Nodules, Multiple, run by Oxford University Hospitals NHS Trust at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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 Lunit INSIGHT CXR is a validation study that aims to assess the utility of an Artificial Intelligence-based (AI) chest X-ray (CXR) interpretation tool in assisting the… Read more about this study

Who is it for?
Any ageHealthy volunteers can take part
What is being tested?
Cases reading and Ground truthing
Type of treatment
Pill or oral medicine
How many people
33 participants
Where
1 siteUnited Kingdom
Study dates
31 Oct 2023to 1 Jun 2025
Phase
Observational
Are there results?
None posted in the registry

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 Any age
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Study population: General radiologists/radiographers/physicians reviewing chest X-rays as part of their routine clinical practice, currently working in the National Health Service (NHS).

Who may be able to join

  • General radiologists/radiographers/physicians who review CXRs as part of their routine clinical practice

Who cannot join

  • Thoracic radiologists
  • Non-radiology physicians with previous formal postgraduate CXR reporting training.
  • Non-radiology physicians with previous career in radiology, respiratory medicine or thoracic surgery to registrar or consultant level

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site
  • Oxford University Hospitals NHS Foundation Trust

    Oxford, Oxfordshire, OX3 9DU

Other trials in United Kingdom

About this study

Official title: Utility of an AI-based CXR Interpretation Tool in Assisting Diagnostic Accuracy, Speed, and Confidence of Healthcare Professionals: a Study Using 500 Retrospectively Collected Inpatient and Emergency Department CXRs From Two UK Hospital Trusts

This study has been added as a sub study to the Simulation Training for Emergency Department Imaging 2 study (ClinicalTrials.gov ID NCT05427838).

The Lunit INSIGHT CXR is a validation study that aims to assess the utility of an Artificial Intelligence-based (AI) chest X-ray (CXR) interpretation tool in assisting the diagnostic accuracy, speed, and confidence of a varied group of healthcare professionals. The study will be conducted using 500 retrospectively collected inpatient and emergency department CXRs from two United Kingdom (UK) hospital trusts. Two fellowship trained thoracic radiologists will independently review all studies to establish the ground truth reference standard. The Lunit INSIGHT CXR tool will be used to analyze each CXR, and its performance will be measured against the expert readers. The study will evaluate the utility of the algorithm in improving reader accuracy and confidence as measured by sensitivity, specificity, positive predictive value, and negative predictive value. The study will measure the performance of the algorithm against ten abnormal findings, including pulmonary nodules/mass, consolidation, pneumothorax, atelectasis, calcification, cardiomegaly, fibrosis, mediastinal widening, pleural effusion, and pneumoperitoneum. The study will involve readers from various clinical professional groups with and without the assistance of Lunit INSIGHT CXR. The study will provide evidence on the impact of AI algorithms in assisting healthcare professionals such as emergency medicine and general medicine physicians who regularly review images in their daily practice.

Being tested
Cases reading, Ground truthing
Keywords
Radiology, Emergency Medicine, Artificial Intelligence, Chest XR, X rays
Medical subject headings
Solitary Pulmonary Nodule, Multiple Pulmonary Nodules, Pneumothorax, Pulmonary Atelectasis, Cardiomegaly, Pulmonary Fibrosis, Pleural Effusion, Bronchiolitis Obliterans Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Cases readingOther

    The reading will be done remotely via the Report and Image Quality Control site (www.RAIQC.com), an online platform allowing medical imaging viewing and reporting. Participants can work from any location, but the work must be done from a computer with internet access. For avoidance of doubt, the work cannot be performed from a phone or tablet.

    The project is divided into two phases and participants are required to complete both phases. The estimated total involvement in the project is up to 20-24 hours.

    Phase 1: Time allowed: 2 weeks

    • Review 500 chest X-rays and express a clinical opinion through a structured reporting template (multiple choice, no open text required).

    Rest/washout period of 2 weeks.

    Phase 2 - Time allowed: 2 weeks

    • Review 500 chest X-rays together with an AI report for each case and express your clinical opinion through the same structured reporting template used in Phase A.
  • Ground truthingOther

    Two consultant thoracic radiologists will independently review the images to establish the 'ground truth' findings on the CXRs, where a consensus is reached this will then be used as the reference standard. In the case of disagreement, a third senior thoracic radiologist's opinion (>20 years experience) will undertake arbitration. A difficulty score will be assigned to each abnormality by the ground truthers using a 4-point Likert scale (1 being easy/obvious to 4 being hard/poorly visualised).

Study groups in NCT06075836
Study groupRoleWhat they receive
Readers/ParticipantsReader Selection: 30 readers will be selected from the following five clinical specialty groups: * emergency medicine (ED) * adult intensive care (ICU) * adult general medicine (AGM) * radiographers (Rad) * general radiologists Each specialty group consists of 6 members of ranked seniority. For the physicians this consists of: * Two 'Juniors' (Foundation Year 1 - Specialty Training 2 years) * Two 'Middle Grades' (Registrar from Specialty Training 3 to 6 years) * Two Consultants For the radiographers, this consists of: * Two 'Junior/Newly qualified radiographers' (up to 18 months experience post qualification) * Two 'Mid-experience radiographers' (approx. 3 years' experience) * Two 'Reporting radiographers' (5+ years' experience)
Receives: Other: Cases reading
Ground truthersTwo consultant thoracic radiologists. A third senior thoracic radiologist's opinion (>20 years experience) will undertake arbitration.
Receives: Other: Ground truthing

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Performance of AI algorithm: sensitivity

    Evaluation of the Lunit INSIGHT CXR algorithm will be performed comparing it to the reference standard in order to determine sensitivity.

    Measured: During 4 weeks of reading time

  2. Performance of AI algorithm: specificity

    Evaluation of the Lunit INSIGHT CXR algorithm will be performed comparing it to the reference standard in order to determine specificity.

    Measured: During 4 weeks of reading time

  3. Performance of AI algorithm: Area under the ROC Curve (AU ROC)

    Evaluation of the Lunit INSIGHT CXR algorithm will be performed comparing it to the reference standard. Continuous probability score from the algorithm will be utilized for the ROC analyses, while binary classification results with a predefined operating cut-off will be used for evaluation of sensitivity, specificity, positive predictive value, and negative predictive value.

    Measured: During 4 weeks of reading time

  4. Performance of readers with and without AI assistance: Sensitivity

    The study will include two sessions (with and without AI overlay), with all 30 readers reviewing all 500 CXR cases each time separated by a washout period to mitigate recall bias. The cases will be randomised between the two reads and for every reader.

    Measured: During 4 weeks of reading time

  5. Performance of readers with and without AI assistance: Specificity

    The study will include two sessions (with and without AI overlay), with all 30 readers reviewing all 500 CXR cases each time separated by a washout period to mitigate recall bias. The cases will be randomised between the two reads and for every reader.

    Measured: During 4 weeks of reading time

  6. Performance of readers with and without AI assistance: Area under the ROC Curve (AU ROC)

    The study will include two sessions (with and without AI overlay), with all 30 readers reviewing all 500 CXR cases each time separated by a washout period to mitigate recall bias. The cases will be randomised between the two reads and for every reader.

    Measured: During 4 weeks of reading time

  7. Reader speed with vs without AI assistance.

    Mean time taken to review a scan, with vs without AI assistance.

    Measured: During 4 weeks of reading time

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Oct 2023
  2. Study start31 Oct 2023
  3. Primary completion31 Oct 2024
  4. Study completion1 Jun 2025

Resources

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
Cohort
Time perspective
Retrospective
Enrolment
33 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06075836
Sponsor's protocol ID
310995 - B
Acronym
AID-CXR
Status last verified
Nov 2025
First submitted
4 Oct 2023
Last updated
24 Nov 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Greenhalgh R, Howlett DC, Drinkwater KJ. Royal College of Radiologists national audit evaluating the provision of imaging in the severely injured patient and compliance with national guidelines. Clin Radiol. 2020 Mar;75(3):224-231. doi: 10.1016/j.crad.2019.10.025. Epub 2019 Dec 19.

    PubMed 31864722
  • Spiritoso R, Padley S, Singh S. Chest X-ray interpretation in UK intensive care units: A survey 2014. J Intensive Care Soc. 2015 Nov;16(4):339-344. doi: 10.1177/1751143715580141. Epub 2015 May 18.

    PubMed 28979441
  • Wilson C. X-ray misinterpretation in urgent care: where does it occur, why does it occur, and does it matter? N Z Med J. 2022 Apr 1;135:49-65.

    PubMed 35728184
  • Jones CM, Buchlak QD, Oakden-Rayner L, Milne M, Seah J, Esmaili N, Hachey B. Chest radiographs and machine learning - Past, present and future. J Med Imaging Radiat Oncol. 2021 Aug;65(5):538-544. doi: 10.1111/1754-9485.13274. Epub 2021 Jun 25.

    PubMed 34169648
  • Ahmad HK, Milne MR, Buchlak QD, Ektas N, Sanderson G, Chamtie H, Karunasena S, Chiang J, Holt X, Tang CHM, Seah JCY, Bottrell G, Esmaili N, Brotchie P, Jones C. Machine Learning Augmented Interpretation of Chest X-rays: A Systematic Review. Diagnostics (Basel). 2023 Feb 15;13(4):743. doi: 10.3390/diagnostics13040743.

    PubMed 36832231
  • van Beek EJR, Ahn JS, Kim MJ, Murchison JT. Validation study of machine-learning chest radiograph software in primary and emergency medicine. Clin Radiol. 2023 Jan;78(1):1-7. doi: 10.1016/j.crad.2022.08.129. Epub 2022 Sep 25.

    PubMed 36171164
  • Kundu R, Das R, Geem ZW, Han GT, Sarkar R. Pneumonia detection in chest X-ray images using an ensemble of deep learning models. PLoS One. 2021 Sep 7;16(9):e0256630. doi: 10.1371/journal.pone.0256630. eCollection 2021.

    PubMed 34492046
  • Matsumoto T, Kodera S, Shinohara H, Ieki H, Yamaguchi T, Higashikuni Y, Kiyosue A, Ito K, Ando J, Takimoto E, Akazawa H, Morita H, Komuro I. Diagnosing Heart Failure from Chest X-Ray Images Using Deep Learning. Int Heart J. 2020 Jul 30;61(4):781-786. doi: 10.1536/ihj.19-714. Epub 2020 Jul 18.

    PubMed 32684597
  • Hillis JM, Bizzo BC, Mercaldo S, Chin JK, Newbury-Chaet I, Digumarthy SR, Gilman MD, Muse VV, Bottrell G, Seah JCY, Jones CM, Kalra MK, Dreyer KJ. Evaluation of an Artificial Intelligence Model for Detection of Pneumothorax and Tension Pneumothorax in Chest Radiographs. JAMA Netw Open. 2022 Dec 1;5(12):e2247172. doi: 10.1001/jamanetworkopen.2022.47172.

    PubMed 36520432
  • Homayounieh F, Digumarthy S, Ebrahimian S, Rueckel J, Hoppe BF, Sabel BO, Conjeti S, Ridder K, Sistermanns M, Wang L, Preuhs A, Ghesu F, Mansoor A, Moghbel M, Botwin A, Singh R, Cartmell S, Patti J, Huemmer C, Fieselmann A, Joerger C, Mirshahzadeh N, Muse V, Kalra M. An Artificial Intelligence-Based Chest X-ray Model on Human Nodule Detection Accuracy From a Multicenter Study. JAMA Netw Open. 2021 Dec 1;4(12):e2141096. doi: 10.1001/jamanetworkopen.2021.41096.

    PubMed 34964851
  • Wu JT, Wong KCL, Gur Y, Ansari N, Karargyris A, Sharma A, Morris M, Saboury B, Ahmad H, Boyko O, Syed A, Jadhav A, Wang H, Pillai A, Kashyap S, Moradi M, Syeda-Mahmood T. Comparison of Chest Radiograph Interpretations by Artificial Intelligence Algorithm vs Radiology Residents. JAMA Netw Open. 2020 Oct 1;3(10):e2022779. doi: 10.1001/jamanetworkopen.2020.22779.

    PubMed 33034642
  • Zech JR, Badgeley MA, Liu M, Costa AB, Titano JJ, Oermann EK. Variable generalization performance of a deep learning model to detect pneumonia in chest radiographs: A cross-sectional study. PLoS Med. 2018 Nov 6;15(11):e1002683. doi: 10.1371/journal.pmed.1002683. eCollection 2018 Nov.

    PubMed 30399157

Questions about this trial

What is this clinical trial studying?

An observational study of Pulmonary Nodules, Solitary and Pulmonary Nodules, Multiple, run by Oxford University Hospitals NHS Trust at 1 site 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 1 inclusion and 3 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: finished, as of the sponsor's last update on 24 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Performance of AI algorithm: sensitivity (time frame: During 4 weeks of reading time). The study lists 7 primary outcomes in all. 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 NCT06075836, which also lists 12 linked publications.

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 24 Nov 2025.

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