NCT06686251 Evaluation of the Efficacy of Diagnostic Support Algorithms in Chest X-rays- LuAna Trial
| NCT ID | NCT06686251 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Hospital Israelita Albert Einstein |
| Condition | Consolidation |
| Study Type | INTERVENTIONAL |
| Enrollment | 1,470 participants |
| Start Date | 2026-01-05 |
| Primary Completion | 2026-06 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 1,470 participants in total. It began in 2026-01-05 with a primary completion date of 2026-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
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.
Contact & Investigator
Joselisa Paiva, PhD
PRINCIPAL INVESTIGATOR
Hospital Israelita Albert Einstein
Frequently Asked Questions
Who can join the NCT06686251 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Consolidation. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06686251 currently recruiting?
Yes, NCT06686251 is actively recruiting participants. Contact the research team at joselisa.paiva@einstein.br for enrollment information.
Where is the NCT06686251 trial being conducted?
This trial is being conducted at Curitiba, Brazil.
Who is sponsoring the NCT06686251 clinical trial?
NCT06686251 is sponsored by Hospital Israelita Albert Einstein. The principal investigator is Joselisa Paiva, PhD at Hospital Israelita Albert Einstein. The trial plans to enroll 1,470 participants.