NCT06686251

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

Evaluation of the Efficacy of Diagnostic Support Algorithms in Chest X-rays - LungAnalysis (LuAna): LuAna Stepped Wedge Trial

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,470 (estimated)
• Sponsor: Hospital Israelita Albert Einstein · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

Imaging diagnostic aid tools that use AI and facilitate the identification of findings on chest x-rays can contribute to doctors' care routines and clinicians' and radiologists' reporting routines, as these tools can allow the organization of care queues according to priorities, in addition to identifying subtle findings on the image, thereby reducing errors in reading the RXT and benefiting patients with greater agility in care and a shorter time until diagnosis. However, for reliability, these tools must undergo rigorous validation processes in large populations before implementation.

Conditions

• Consolidation
• Lung Injury
• Pleural Effusion
• Pneumothorax
• Cardiomegaly
• Edema Lung

Interventions

Type	Name	Description
DEVICE	App LuAna	Inclusion of chest x-ray images in the LuAna app to receive feedback on lung findings.

Timeline

• Start date: 2026-01-05
• Primary completion: 2026-06-01
• Completion: 2026-12-01
• First posted: 2024-11-13
• Last updated: 2026-02-02

Locations

1 site across 1 country: Brazil