Lung NeoplasmsAI-ROSE-FEASNCT07662967
Feasibility and Preliminary Performance of an AI Prototype for Digital ROSE During EBUS-TBNA and Peripheral TBNA: a Prospective Pilot Study (AI-ROSE-FEAS)
An observational study of Lung Neoplasms and Bronchoscopy, run by Azienda Ospedaliera di Rilievo Nazionale A.Cardarelli.
Trial summary
Rapid On-Site Evaluation (ROSE) of cytological slides obtained during EBUS-TBNA improves diagnostic yield by providing real-time adequacy assessment and preliminary diagnostic orientation after each needle pass. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Neoplasms, Bronchoscopy, AI (Artificial Intelligence)
- What is being tested?
- ROSE
- How many people
- 65 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2026to Mar 2027
- How long will I take part?
- 6 Months
- Phase
- Observational
- 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
Study population: patients with clinical indication for diagnostic bronchoscopy with EBUS-TBNA for mediastinal lymphadenopathy and/or TBNA on peripheral lung lesions, according to ACCP/ERS-ESTS guidelines and the Unit's diagnostic pathways.
Who may be able to join
- Age ≥ 18 years.
- Clinical indication for diagnostic bronchoscopy with EBUS-TBNA for mediastinal lymphadenopathy and/or TBNA on peripheral lung lesions, according to ACCP/ERS-ESTS guidelines and the Unit's diagnostic pathways.
- The procedure will be performed in two-person mode with IP-ROSE performed as per the center's SOP.
- Ability to provide written informed consent.
- Willingness to undergo the required follow-up.
Who cannot join
- Absolute contraindications to bronchoscopy.
- Known histological diagnosis of the target lesion (except re-staging).
- Concomitant interventional procedures that alter the standard sequence.
- Inability to provide written informed consent.
- Any condition that, in the investigator's judgment, compromises patient safety or the reliability of the data.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Preliminary Feasibility and Diagnostic Performance of an Investigational Artificial Intelligence Prototype for Digital Rapid On-Site Evaluation (ROSE) of Cytological Slides During Diagnostic Bronchoscopy With Endobronchial Ultrasound-Guided Transbronchial Needle Aspiration (EBUS-TBNA) and Peripheral Transbronchial Needle Aspiration: a Prospective Monocentric Pilot Study (AI-ROSE-FEAS)
Rapid On-Site Evaluation (ROSE) of cytological slides obtained during EBUS-TBNA improves diagnostic yield by providing real-time adequacy assessment and preliminary diagnostic orientation after each needle pass. In centers without a dedicated cytopathologist, ROSE is performed by a second interventional pulmonologist acting as a dedicated ROSE operator (interventional pulmonologist-performed ROSE, IP-ROSE), a model associated with good but variable diagnostic performance compared to cytopathologist-performed ROSE.
This study evaluates the feasibility and preliminary diagnostic performance of an investigational artificial intelligence prototype for digital ROSE. The prototype, developed in-house by the Principal Investigator, analyzes microscopic images of Diff-Quik stained cytological slides acquired through a dedicated digital microscope, together with basic clinical data, via API calls to a multimodal AI model. It produces two outputs: sample adequacy (appropriate/not appropriate) and malignancy suspicion (benign/malignant), each with a confidence score. The AI output is recorded in the study database for research purposes only and is not shown to the operator in real time; it does not influence clinical decisions during the procedure.
Read more
The study is a prospective, monocentric, observational pilot study enrolling 65 adult patients undergoing EBUS-TBNA or peripheral TBNA with IP-ROSE at a single interventional pulmonology unit. The primary statistical unit is the individual ROSE slide, with an expected 130 to 160 evaluable slides. Co-primary endpoints are: (1) technical feasibility of the AI prototype, defined as the proportion of slides with valid AI output within 90 seconds; and (2) AI accuracy for sample adequacy assessment compared to the definitive cytopathological diagnosis, with an expected 95% confidence interval precision of ±5.5%. Secondary endpoints include AI accuracy for malignancy suspicion, agreement between the AI prototype and the IP-ROSE operator, and AI output latency.
The AI prototype is not a commercially approved or CE-marked medical device. It was developed internally by the Principal Investigator for research purposes and is evaluated exclusively within this study. Data from this pilot study will inform the design of a subsequent confirmatory non-inferiority trial, which will be the subject of separate registration and ethical approval.
- Conditions
- Lung Neoplasms, Bronchoscopy, AI (Artificial Intelligence), Mediastinal ( Chest) Masses, Mediastinal Lymphadenopathy, EBUS Guided Transbronchial Needle Aspiration
- Being tested
- ROSE
- Keywords
- bronchoscopy, artificial intelligence
- Medical subject headings
- Lung Neoplasms, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ROSEDiagnostic test
Also called AI-ROSE, IP-ROSE
Bronchologist's Rapid On Site Evaluation (ROSE) compared with those of the AI and then compared with the pathological anatomy report
| Study group | Role | What they receive |
|---|---|---|
| patients with an indication for diagnostic bronchoscopy | patients with an indication for diagnostic bronchoscopy for suspected malignant disease of the lung or mediastinum or for suspected interstitial lung disease Receives: Diagnostic Test: ROSE |
What is being measured
The primary outcome is the main question the study is designed to answer.
technical feasibility of the AI prototype
technical feasibility of the AI prototype, defined as the proportion of slides with valid AI output within 90 seconds
Measured: 6 months
AI accuracy
AI accuracy for sample adequacy assessment compared to the definitive cytopathological diagnosis, with an expected 95% confidence interval precision of ±5.5%
Measured: 6 months
Secondary outcomes (3)
AI accuracy for malignancy suspicion
AI accuracy for malignancy suspicion
Measured: 6 months
Agreement between the AI prototype and the IP-ROSE operator
Agreement between the AI prototype and the IP-ROSE operator
Measured: 6 months
AI output latency
AI output latency
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2026
- Study start1 Jul 2026 (estimated)
- Primary completionAug 2026 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung NeoplasmsStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 65 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliera di Rilievo Nazionale A.Cardarelli
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Matilde Boccia, Azienda Ospedaliera di Rilievo Nazionale A.Cardarelli
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07662967
- Sponsor's protocol ID
- AI-ROSE-FEAS
- Acronym
- AI-ROSE-FEAS
- Status last verified
- Jun 2026
- First submitted
- 17 Jun 2026
- Last updated
- 23 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preliminary Feasibility and Diagnostic Performance of an Investigational Artificial Intelligence Prototype for Digital Rapid On-Site Evaluation (ROSE) of Cytological Slides During Diagnostic Bronchoscopy With Endobronchial Ultrasound-Guided Transbronchial Needle Aspiration (EBUS-TBNA) and Peripheral Transbronchial Needle Aspiration: a Prospective Monocentric Pilot Study (AI-ROSE-FEAS)
- ClinicalTrials.gov ID
- NCT07662967
- Acronym / sponsor ID
- AI-ROSE-FEAS / AI-ROSE-FEAS
- Conditions
- Lung Neoplasms, Bronchoscopy, AI (Artificial Intelligence), Mediastinal ( Chest) Masses, Mediastinal Lymphadenopathy, EBUS Guided Transbronchial Needle Aspiration
- Keywords
- bronchoscopy, artificial intelligence
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 65 participants (estimated)
- Lead sponsor
- Azienda Ospedaliera di Rilievo Nazionale A.CardarelliUniversity, hospital or other
- Study start
- 1 Jul 2026 (estimated)
- Primary completion
- Aug 2026 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 23 Jun 2026 (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.
Rapid On-Site Evaluation (ROSE) of cytological slides obtained during EBUS-TBNA improves diagnostic yield by providing real-time adequacy assessment and preliminary diagnostic orientation after each needle pass. In centers without a dedicated cytopathologist, ROSE is performed by a second interventional pulmonologist acting as a dedicated ROSE operator (interventional pulmonologist-performed ROSE, IP-ROSE), a model associated with good but variable diagnostic performance compared to cytopathologist-performed ROSE.
This study evaluates the feasibility and preliminary diagnostic performance of an investigational artificial intelligence prototype for digital ROSE. The prototype, developed in-house by the Principal Investigator, analyzes microscopic images of Diff-Quik stained cytological slides acquired through a dedicated digital microscope, together with basic clinical data, via API calls to a multimodal AI model. It produces two outputs: sample adequacy (appropriate/not appropriate) and malignancy suspicion (benign/malignant), each with a confidence score. The AI output is recorded in the study database for research purposes only and is not shown to the operator in real time; it does not influence clinical decisions during the procedure.
The study is a prospective, monocentric, observational pilot study enrolling 65 adult patients undergoing EBUS-TBNA or peripheral TBNA with IP-ROSE at a single interventional pulmonology unit. The primary statistical unit is the individual ROSE slide, with an expected 130 to 160 evaluable slides. Co-primary endpoints are: (1) technical feasibility of the AI prototype, defined as the proportion of slides with valid AI output within 90 seconds; and (2) AI accuracy for sample adequacy assessment compared to the definitive cytopathological diagnosis, with an expected 95% confidence interval precision of ±5.5%. Secondary endpoints include AI accuracy for malignancy suspicion, agreement between the AI prototype and the IP-ROSE operator, and AI output latency.
The AI prototype is not a commercially approved or CE-marked medical device. It was developed internally by the Principal Investigator for research purposes and is evaluated exclusively within this study. Data from this pilot study will inform the design of a subsequent confirmatory non-inferiority trial, which will be the subject of separate registration and ethical approval.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients with an indication for diagnostic bronchoscopy | – | Diagnostic Test: ROSEpatients with an indication for diagnostic bronchoscopy for suspected malignant disease of the lung or mediastinum or for suspected interstitial lung disease |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with clinical indication for diagnostic bronchoscopy with EBUS-TBNA for mediastinal lymphadenopathy and/or TBNA on peripheral lung lesions, according to ACCP/ERS-ESTS guidelines and the Unit's diagnostic pathways.
Key inclusion criteria (5 listed)
- Age ≥ 18 years.
- Clinical indication for diagnostic bronchoscopy with EBUS-TBNA for mediastinal lymphadenopathy and/or TBNA on peripheral lung lesions, according to ACCP/ERS-ESTS guidelines and the Unit's diagnostic pathways.
- The procedure will be performed in two-person mode with IP-ROSE performed as per the center's SOP.
- Ability to provide written informed consent.
- Willingness to undergo the required follow-up.
Key exclusion criteria (5 listed)
- Absolute contraindications to bronchoscopy.
- Known histological diagnosis of the target lesion (except re-staging).
- Concomitant interventional procedures that alter the standard sequence.
- Inability to provide written informed consent.
- Any condition that, in the investigator's judgment, compromises patient safety or the reliability of the data.
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 |
|---|---|---|
| ROSEAlso: AI-ROSE, IP-ROSEBronchologist's Rapid On Site Evaluation (ROSE) compared with those of the AI and then compared with the pathological anatomy report | Diagnostic test | patients with an indication for diagnostic bronchoscopy |
Primary outcome
technical feasibility of the AI prototype
Time frame: 6 months
technical feasibility of the AI prototype, defined as the proportion of slides with valid AI output within 90 seconds
AI accuracy
Time frame: 6 months
AI accuracy for sample adequacy assessment compared to the definitive cytopathological diagnosis, with an expected 95% confidence interval precision of ±5.5%
3 secondary outcomes
AI accuracy for malignancy suspicion
Time frame: 6 months
Agreement between the AI prototype and the IP-ROSE operator
Time frame: 6 months
AI output latency
Time frame: 6 months
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 23 Jun 2026.
- 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.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Neoplasms and Bronchoscopy, run by Azienda Ospedaliera di Rilievo Nazionale A.Cardarelli.
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 5 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: opening soon, as of the sponsor's last update on 23 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
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 Matilde Boccia, Medical Doctor (+39 0817473393, matilde.boccia@aocardarelli.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
technical feasibility of the AI prototype (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Jun 2026.