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NCT Number: NCT06686251

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

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

FEAS Curitiba

Curitiba, Paraná, 81130-160, Brazil

Location status: Recruiting

Location contact

Romulo Pereira, PI

CONTACT

+55 41999430693

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

App LuAna

Device

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

Primary outcomes

  1. Detection rate

    Time frame: through study completion, an average of 1 year

    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).

Study contacts

Contact information is provided by the study sponsor or research team.

Joselisa Paiva, PhD

CONTACT

[email protected]

+55 (11) 9981667340

Sponsors and collaborators

Lead sponsor

Hospital Israelita Albert Einstein

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Nov 13, 2024
Registry last updated
Feb 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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