Evaluation of the Efficacy of Diagnostic Support Algorithms in Chest X-rays- LuAna Trial
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorHospital Israelita Albert Einstein
About this trial
This study aims to evaluate whether the use of AI as a physician support tool is associated with an increase in the detection rate of chest radiographic findings in adults with respiratory complaints, compared to diagnosis performed exclusively by doctors, without AI support. This is a cluster-randomized clinical trial, following the stepped wedge design, and adhering to the guidelines of the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT). In this study, the Diagnostic Support Solution for Chest X-rays - LungAnalysis (LuAna), developed by the Hospital Israelita Albert Einstein (HIAE) within the PROADI-SUS Banco de Imagens, was used.
The clinical trial will be conducted in multiple centers with a diverse population from the public health system, to ensure that the algorithms are validated across a broad demographic profile. The expected benefits are significant, providing greater security for patients, increasing doctors' confidence in interpreting chest X-rays, promoting efficiency and cost savings for healthcare services, and offering promising prospects for other AI applications in imaging diagnostics.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Non-reported chest X-rays (XRts) of individuals aged over 18 years.
Individuals images with respiratory complaints.
Chest X-rays taken during the presence of these respiratory symptoms or while being followed up for respiratory disease.
Chest X-rays taken on any X-ray machine.
Disqualifiers
Those whose chest X-ray was performed due to a history of trauma, pre-operative risk assessment, lung cancer screening, or exclusively for verifying the correct positioning of a peripheral intravenous catheter (PICC).
Chest X-rays with technical quality below the minimum required for proper interpretation and diagnosis.
Cases without at least one frontal view.
X-rays printed on regular paper.
Trial design
Design model
Single group
Treatments tested in this trial
App LuAna
DeviceInclusion of chest x-ray images in the LuAna app to receive feedback on lung findings.
Treatment groups
2,400 Participants
are divided into 1 treatment groupGroup A: App LuAnaExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Detection rate
Detection rate of "Radiological Findings", before and after Artificial Intelligence assistance, compared to gold standard (report validated twice by thoracic radiologists blind to the interpretation of the examining physician and AI result).
Time frame
through study completion, an average of 1 yearSponsors and contacts
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Source ClinicalTrials.gov