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

NCT06686251 | Recruiting DMC

• 1 other identifier: LuAna Trial
• Study Type: interventional
• Target: 1,470
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Artificial Intelligence; Chest X-ray; Stepped wedge trial

Outcome Measures

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).

  through study completion, an average of 1 year

Study Arms (1)

App LuAna

EXPERIMENTAL

feedback of the artificial intelligence after the inclusion image in app LuAna.

Device: App LuAna

Interventions

App LuAna DEVICE

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

App LuAna

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital Israelita Albert Einstein: lead

Study Sites (1)

FEAS Curitiba

Curitiba, Paraná, 81130-160, Brazil

RECRUITING

MeSH Terms

Conditions

Lung Injury; Pleural Effusion; Pneumothorax; Cardiomegaly; Pulmonary Edema

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Thoracic Injuries; Wounds and Injuries; Pleural Diseases; Heart Diseases; Cardiovascular Diseases; Hypertrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Joselisa Paiva, PhD

  Hospital Israelita Albert Einstein

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Joselisa Paiva, PhD

CONTACT

+55 (11) 9981667340; joselisa.paiva@einstein.br

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a type of "stepped wedge" cluster randomized clinical trial. In the model standard of this design, interventions are implemented in the clusters randomly and graduate.

Study Record Dates

• First Submitted: November 7, 2024
• First Posted: November 13, 2024
• Study Start: January 5, 2026
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: February 2, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)