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AI Assisted Detection of Chest X-Rays

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	Yes
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Observational
Eligible Ages	N/A and Over
Gender	All

More Inclusion & Exclusion Criteria

Inclusion Criteria:

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

Exclusion Criteria:

- 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 Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT06075836
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Oxford University Hospitals NHS Trust
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	N/A
Principal Investigator Affiliation	N/A
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Active, not recruiting
Countries	United Kingdom
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Pulmonary Nodules, Solitary, Pulmonary Nodules, Multiple, Pulmonary Consolidation, Pneumothorax, Pneumothorax; Acute, Atelectasis, Pulmonary Calcification, Cardiomegaly, Fibrosis Lung, Pleural Effusion, Pleural Effusions, Chronic, Pneumoperitoneum
Study Website:	View Trial Website

Arms & Interventions

Arms

: Readers/Participants

Reader 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)

: Ground truthers

Two consultant thoracic radiologists. A third senior thoracic radiologist's opinion (>20 years experience) will undertake arbitration.

Interventions

Other: - Cases reading

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.

Other: - Ground truthing

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).

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Oxford, Oxfordshire, United Kingdom

Status

Address

Oxford University Hospitals NHS Foundation Trust

Oxford, Oxfordshire, OX3 9DU

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