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Evaluation of the Efficacy of Diagnostic Support Algorithms in Chest X-rays- LuAna Trial

Sponsor: Hospital Israelita Albert Einstein • ClinicalTrials.gov ID: NCT06686251

Registry updated: 2026-09-16

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Description

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.

Interventions

App LuAna (Device)
Inclusion of chest x-ray images in the LuAna app to receive feedback on lung findings.

Eligibility criteria

Inclusion Criteria: * 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. * Chest X-rays that include at least one frontal view of the chest. Exclusion Criteria: * 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.

Conditions

Consolidation Lung Injury Pleural Effusion Pneumothorax Cardiomegaly Edema Lung

Locations

FEAS Curitiba — Curitiba, Paraná, Brazil

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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