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RecruitingNCT06686251Updated Sep 16, 2026

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

An interventional study of App LuAna in Consolidation, Lung Injury and Pleural Effusion, sponsored by Hospital Israelita Albert Einstein. Recruiting at 1 site in Brazil. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-16.

Sponsored by Hospital Israelita Albert Einstein · Not applicable, Interventional, and Other

From the registry’s dates

  • Started Jan 2026; still recruiting 10 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
2,400
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

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

Keywords

  • Artificial Intelligence
  • Chest X-ray
  • Stepped wedge trial
03

In context

Lung Injury

114 studies on the registry are indexed under Lung Injury; 33 are open to participants now.

This study's planned enrollment of 2,400 is above the median of 62 across 75 interventional studies indexed under Lung Injury.

Browse Lung Injury studies →

Lead sponsor

Hospital Israelita Albert Einstein is the lead sponsor of 147 studies on the registry; 32 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
2,400 participants (estimated)

Study arms

  • Experimental
    App LuAna

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

    Device: App LuAna

Interventions

  • DeviceApp LuAna

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

06

What researchers measure

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).

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

07

Study locations

1 of 1 sites recruiting
  • FEAS Curitiba
    Curitiba, Paraná 81130-160, Brazil
    Recruiting
    • Romulo Pereira, PI · Contact+55 41999430693
08

References and documents

Publications

  • da Silva MCB, de Andrade PBM, Lee HMH, Silva PVA, Ferreira AC, Kuss CP, Rodrigues MGA, Ribeiro GAS, Camargo TFO, Fan WYC, Netto PVS, Mendes GS, Szarf G, Loureiro RM, Serpa Neto A, Paiva JPQ, Horvath JDC. AI-Assisted Chest X-Ray Interpretation in Resource-Limited Settings: LuAna Stepped-Wedge Trial Protocol. JMIR Res Protoc. 2026 Jul 13;15:e88626. doi: 10.2196/88626. PubMed 42441741 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jan 2026 (actual). Primary completion is estimated for Oct 2026, 9 months after the start.

Of 28 interventional studies with no phase under Lung Injury, half reached primary completion within 38 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 69. This study's planned 9 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 7, 2024
First posted
Nov 13, 2024
StartActual
Jan 5, 2026
Primary completionEst.
Oct 31, 2026
CompletionEst.
Dec 1, 2026
Last update
Sep 16, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 16, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06686251
Responsible party
Sponsor
First posted
Nov 13, 2024
Start date
Jan 5, 2026
Primary completion
Oct 31, 2026 (estimated)
Completion
Dec 1, 2026 (estimated)
Last update
Sep 16, 2026

Study contacts

Joselisa Paiva, PhD
Contact
joselisa.paiva@einstein.br
+55 (11) 9981667340
Joselisa Paiva, PhD
principal investigator · Hospital Israelita Albert Einstein

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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