ConsolidationNCT06686251
Evaluation of the Efficacy of Diagnostic Support Algorithms in Chest X-rays- LuAna Trial
A study testing App LuAna in people with Consolidation and Lung Injury, run by Hospital Israelita Albert Einstein at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Consolidation, Lung Injury, Pleural Effusion
- What is being tested?
- App LuAna
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,400 participants
- Where
- 1 siteBrazil
- Study dates
- 5 Jan 2026to 1 Dec 2026
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Brazil1 site, 1 recruiting
- Recruiting
FEAS Curitiba
Curitiba, Paraná, 81130-160
Romulo Pereira, PI, +55 41999430693
About this study
Official title: Evaluation of the Efficacy of Diagnostic Support Algorithms in Chest X-rays - LungAnalysis (LuAna): LuAna Stepped Wedge 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.
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.
- Conditions
- Consolidation, Lung Injury, Pleural Effusion, Pneumothorax, Cardiomegaly, Edema Lung
- Being tested
- App LuAna
- Keywords
- Artificial Intelligence, Chest X-ray, Stepped wedge trial
- Medical subject headings
- Lung Injury, Pleural Effusion, Pneumothorax, Cardiomegaly, Pulmonary Edema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
App LuAnaDevice
Inclusion of chest x-ray images in the LuAna app to receive feedback on lung findings.
| Study group | Role | What they receive |
|---|---|---|
| App LuAna | Experimental | feedback of the artificial intelligence after the inclusion image in app LuAna. Receives: Device: App LuAna |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2024
- Study start5 Jan 2026
- Primary completion31 Oct 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ConsolidationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 2,400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Israelita Albert Einstein
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Joselisa Paiva, PhD, Principal investigator, Hospital Israelita Albert Einstein
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06686251
- Sponsor's protocol ID
- LuAna Trial
- Status last verified
- Jan 2026
- First submitted
- 7 Nov 2024
- Last updated
- 16 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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