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
- Are there results?
- Not yet: the study is under way
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
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Efficacy of Diagnostic Support Algorithms in Chest X-rays - LungAnalysis (LuAna): LuAna Stepped Wedge Trial
- ClinicalTrials.gov ID
- NCT06686251
- Acronym / sponsor ID
- LuAna Trial
- Conditions
- Consolidation, Lung Injury, Pleural Effusion, Pneumothorax, Cardiomegaly, Edema Lung
- Keywords
- Artificial Intelligence, Chest X-ray, Stepped wedge trial
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 2,400 participants (estimated)
- Lead sponsor
- Hospital Israelita Albert EinsteinUniversity, hospital or other
- Study start
- 5 Jan 2026 (actual)
- Primary completion
- 31 Oct 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 13 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| App LuAna | Experimental | Device: App LuAnafeedback of the artificial intelligence after the inclusion image in app LuAna. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| App LuAnaInclusion of chest x-ray images in the LuAna app to receive feedback on lung findings. | Device | App LuAna |
Primary outcome
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).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2026.
- Derived from this study: PubMed 42441741da 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Joselisa Paiva, PhD principal investigator
Hospital Israelita Albert Einstein
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing App LuAna in people with Consolidation and Lung Injury, run by Hospital Israelita Albert Einstein at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Joselisa Paiva, PhD (+55 (11) 9981667340, joselisa.paiva@einstein.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Detection rate (time frame: through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06686251, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2026.