Lung CarcinomaNCT05556525
Needle-Based Confocal Laser Endomicroscopy for Diagnosis of Lung Cancer in Patients With Peripheral Pulmonary Nodules
A study testing Fluorescein, Image-Guided Needle Confocal Laser Endomicroscopy and Ultrasound-Guided Transbronchial Needle Aspiration in people with Lung Carcinoma, run by Mayo Clinic at 1 site in United States.
Trial summary
This clinical trial compares the addition of needle-based confocal laser endomicroscopy (nCLE) and fluorescein to endobronchial ultrasound-guided transbronchial needle aspiration (EBUS TBNA) with EBUS TBNA alone for the diagnosis of lung cancer in patients with peripheral pulmonary nodules. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Lung Carcinoma
- What is being tested?
- Fluorescein, Image-Guided Needle Confocal Laser Endomicroscopy and Ultrasound-Guided Transbronchial Needle Aspiration
- Type of treatment
- Injection or infusion, Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- 12 May 2023to 25 Oct 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- >= 21 years of age
- Suspected PPN
- Nodule size in computed tomography (CT) between 8 mm and 30 mm (largest dimension)
- Ability to understand and willingness to sign a written informed consent and Health Insurance Portability and Accountability Act (HIPAA) consent document
Who cannot join
- Inability or non-willingness to provide informed consent
- Failure to comply with the study protocol
- Patients with known allergy for fluorescein or risk factors for an allergic reaction
- Use of beta-blocker within 24 hours before the start of the bronchoscopic procedure
- Possibly pregnant, pregnant or breastfeeding women
- Patients with hemodynamic instability
Show all 14Show fewer
- Patients with refractory hypoxemia
- Patients with a therapeutic anticoagulant that cannot be held for an appropriate interval before the procedure
- Patients who are unable to tolerate general anesthesia according to the anesthesiologist
- Patient undergoing chemotherapy
- INTRA-OPERATIVE EXCLUSION/STOPPING CRITERIA:
- The lesions are unable to be localized/confirmed by bronchoscopy
- The procedure will be terminated if the patient develops a significant procedural complication as determined by the treating physician
- The procedure will be terminated if the patient develops hemodynamic instability as determined by the treating physician
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic in Florida
Jacksonville, Florida, 32224-9980
About this study
Official title: nCLE Guided Randomized Controlled Trial for Lung Cancer Diagnosis
This clinical trial compares the addition of needle-based confocal laser endomicroscopy (nCLE) and fluorescein to endobronchial ultrasound-guided transbronchial needle aspiration (EBUS TBNA) with EBUS TBNA alone for the diagnosis of lung cancer in patients with peripheral pulmonary nodules. EBUS TBNA is a diagnostic procedure that can be used to sample lung tissue. nCLE is a novel high-resolution imaging technique that uses a laser light to create real-time microscopic images of tissues. It can be integrated into needles allowing real-time cancer detection during endoscopy. Fluorescein is an imaging agent that can be used to visualize tissue. Using nCLE and fluorescein in combination with EBUS TBNA may be more effective in diagnosing lung cancer than using EBUS TBNA alone.
Read the detailed description
PRIMARY OBJECTIVE:
- To compare the first-pass diagnostic yield of the sequential needle passes (rapid on-site evaluation [ROSE]) between the robotic-nCLE-TBNA arm and the robotic-guided arm in peripheral pulmonary nodule (PPNs).
SECONDARY OBJECTIVES:
- To compare the per-patient diagnostic yield (cumulative pass diagnostic yield: cumulative number of passes until five cumulated passes) of robotic-nCLE-guided TBNA to that of robotic-guided TBNA in PPNs.
II. To compare the proportion of patients with lung cancer treatment in the robotic-nCLE-guided TBNA arm to that of the robotic-guided TBNA arm in PPNs.
III. To compare the proportion of patients with follow-up (video-assisted thoracoscopic surgery [VATS]) or transthoracic needle aspiration (TTNA) or TBNA procedures in the robotic-nCLE-guided TBNA arm to that of the robotic-guided TBNA arm in PPNs.
IV. To compare the number of passes needed to obtain a final diagnosis of robotic-nCLE-guided TBNA to that of robotic-guided TBNA in PPNs.
- To assess the diagnostic performance (sensitivity, specificity, positive predictive value [PPV], negative predictive value [NPV], accuracy) of the sequential cumulative nCLE passes and the sequential cumulative ROSE passes using the final diagnosis as a reference.
VI. To assess the feasibility by obtaining adequate confocal laser endomicroscopy (CLE) video footage in > 80% of the PPN punctures.
VII. To assess the safety of nCLE imaging, as defined by:
VIIa. The number and frequency of all adverse events (AE)/serious adverse events (SAE) from the start of the procedure until end of 12-month follow-up; VIIb. The number and frequency of nCLE procedure-related AE/SAE from the start of the procedure until end of 12-month follow-up.
VIII. To assess the reproducibility of nCLE criteria to the reference standard. Three nCLE characteristics for the detection of malignancy were identified during Wijmans et al. study:
VIIIa. Dark enlarged pleomorphic cells; VIIIb. Dark cell clusters consist of overlapping cell structures ('dark clumps') and; VIIIc. Continuous movement of the cells in one direction ('directional streaming').
IX. To create an nCLE image atlas for malignant characteristics in PPNs.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients undergo robotic EBUS TBNA on study.
ARM II: Patients undergo EBUS TBNA, nCLE, and receive fluorescein intravenously (IV) on study.
- Conditions
- Lung Carcinoma
- Being tested
- Fluorescein, Image-Guided Needle Confocal Laser Endomicroscopy, Ultrasound-Guided Transbronchial Needle Aspiration
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FluoresceinOther
Given IV
Image-Guided Needle Confocal Laser EndomicroscopyDevice
Undergo nCLE
Ultrasound-Guided Transbronchial Needle AspirationProcedure or surgery
Also called EBUS-TBNA, Endobronchial Ultrasound-Guided Transbronchial Needle Aspiration
Undergo EBUS TBNA
| Study group | Role | What they receive |
|---|---|---|
| Arm I (EBUS TBNA) | Active comparator | Patients undergo robotic EBUS TBNA on study. Receives: Procedure: Ultrasound-Guided Transbronchial Needle Aspiration |
| Arm II (EBUS TBNA, nCLE, fluorescein) | Experimental | Patients undergo EBUS TBNA, nCLE, and receive fluorescein IV on study. Receives: Other: Fluorescein; Device: Image-Guided Needle Confocal Laser Endomicroscopy; Procedure: Ultrasound-Guided Transbronchial Needle Aspiration |
What is being measured
The primary outcome is the main question the study is designed to answer.
First-pass Diagnostic Yield
Calculated as the proportion of patients for which first-pass transbronchial needle aspiration during bronchoscopic procedure yielded a definitive diagnosis out of the total number of patients that have received a diagnostic procedure.
Measured: Baseline
Secondary outcomes (1)
Per-patient Diagnostic Yield
Calculated as the proportion of patients in whom the bronchoscopic procedure yielded a definitive diagnosis out of the total number of patients that have received a diagnostic procedure. Per patient diagnostic yield of each bronchoscopic procedure will be calculated, and the accuracy of each technique using the final/definitive diagnosis as the reference. The diagnostic yield and accuracy for each method will be compared.
Measured: Baseline to 12 months following procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2022
- Study start12 May 2023
- Primary completion3 Jun 2024
- Study completion25 Oct 2024
Why it stopped: Slow accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Lung CarcinomaStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sebastian Fernandez-Bussy, M.D., Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05556525
- Sponsor's protocol ID
- MKT_2021_lung_01
- Other IDs
- NCI-2022-07660, 21-008276
- Status last verified
- Jul 2025
- First submitted
- 23 Sep 2022
- Last updated
- 17 Sep 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- nCLE Guided Randomized Controlled Trial for Lung Cancer Diagnosis
- ClinicalTrials.gov ID
- NCT05556525
- Acronym / sponsor ID
- MKT_2021_lung_01
- Conditions
- Lung Carcinoma
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Slow accrual
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 12 May 2023 (actual)
- Primary completion
- 3 Jun 2024 (actual)
- Study completion
- 25 Oct 2024 (actual)
- First posted
- 27 Sep 2022 (actual)
- Results
- Posted 17 Sep 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This clinical trial compares the addition of needle-based confocal laser endomicroscopy (nCLE) and fluorescein to endobronchial ultrasound-guided transbronchial needle aspiration (EBUS TBNA) with EBUS TBNA alone for the diagnosis of lung cancer in patients with peripheral pulmonary nodules. EBUS TBNA is a diagnostic procedure that can be used to sample lung tissue. nCLE is a novel high-resolution imaging technique that uses a laser light to create real-time microscopic images of tissues. It can be integrated into needles allowing real-time cancer detection during endoscopy. Fluorescein is an imaging agent that can be used to visualize tissue. Using nCLE and fluorescein in combination with EBUS TBNA may be more effective in diagnosing lung cancer than using EBUS TBNA alone.
Detailed description
PRIMARY OBJECTIVE:
- To compare the first-pass diagnostic yield of the sequential needle passes (rapid on-site evaluation [ROSE]) between the robotic-nCLE-TBNA arm and the robotic-guided arm in peripheral pulmonary nodule (PPNs).
SECONDARY OBJECTIVES:
- To compare the per-patient diagnostic yield (cumulative pass diagnostic yield: cumulative number of passes until five cumulated passes) of robotic-nCLE-guided TBNA to that of robotic-guided TBNA in PPNs.
II. To compare the proportion of patients with lung cancer treatment in the robotic-nCLE-guided TBNA arm to that of the robotic-guided TBNA arm in PPNs.
III. To compare the proportion of patients with follow-up (video-assisted thoracoscopic surgery [VATS]) or transthoracic needle aspiration (TTNA) or TBNA procedures in the robotic-nCLE-guided TBNA arm to that of the robotic-guided TBNA arm in PPNs.
IV. To compare the number of passes needed to obtain a final diagnosis of robotic-nCLE-guided TBNA to that of robotic-guided TBNA in PPNs.
- To assess the diagnostic performance (sensitivity, specificity, positive predictive value [PPV], negative predictive value [NPV], accuracy) of the sequential cumulative nCLE passes and the sequential cumulative ROSE passes using the final diagnosis as a reference.
VI. To assess the feasibility by obtaining adequate confocal laser endomicroscopy (CLE) video footage in > 80% of the PPN punctures.
VII. To assess the safety of nCLE imaging, as defined by:
VIIa. The number and frequency of all adverse events (AE)/serious adverse events (SAE) from the start of the procedure until end of 12-month follow-up; VIIb. The number and frequency of nCLE procedure-related AE/SAE from the start of the procedure until end of 12-month follow-up.
VIII. To assess the reproducibility of nCLE criteria to the reference standard. Three nCLE characteristics for the detection of malignancy were identified during Wijmans et al. study:
VIIIa. Dark enlarged pleomorphic cells; VIIIb. Dark cell clusters consist of overlapping cell structures ('dark clumps') and; VIIIc. Continuous movement of the cells in one direction ('directional streaming').
IX. To create an nCLE image atlas for malignant characteristics in PPNs.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients undergo robotic EBUS TBNA on study.
ARM II: Patients undergo EBUS TBNA, nCLE, and receive fluorescein intravenously (IV) on study.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I (EBUS TBNA) | Active comparator | Procedure: Ultrasound-Guided Transbronchial Needle AspirationPatients undergo robotic EBUS TBNA on study. |
| Arm II (EBUS TBNA, nCLE, fluorescein) | Experimental | Other: Fluorescein, Device: Image-Guided Needle Confocal Laser Endomicroscopy, Procedure: Ultrasound-Guided Transbronchial Needle AspirationPatients undergo EBUS TBNA, nCLE, and receive fluorescein IV on study. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- >= 21 years of age
- Suspected PPN
- Nodule size in computed tomography (CT) between 8 mm and 30 mm (largest dimension)
- Ability to understand and willingness to sign a written informed consent and Health Insurance Portability and Accountability Act (HIPAA) consent document
Key exclusion criteria (14 listed)
- Inability or non-willingness to provide informed consent
- Failure to comply with the study protocol
- Patients with known allergy for fluorescein or risk factors for an allergic reaction
- Use of beta-blocker within 24 hours before the start of the bronchoscopic procedure
- Possibly pregnant, pregnant or breastfeeding women
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 |
|---|---|---|
| FluoresceinGiven IV | Other | Arm II (EBUS TBNA, nCLE, fluorescein) |
| Image-Guided Needle Confocal Laser EndomicroscopyUndergo nCLE | Device | Arm II (EBUS TBNA, nCLE, fluorescein) |
| Ultrasound-Guided Transbronchial Needle AspirationAlso: EBUS-TBNA, Endobronchial Ultrasound-Guided Transbronchial Needle AspirationUndergo EBUS TBNA | Procedure or surgery | Arm I (EBUS TBNA), Arm II (EBUS TBNA, nCLE, fluorescein) |
Primary outcome
First-pass Diagnostic Yield
Time frame: Baseline
Calculated as the proportion of patients for which first-pass transbronchial needle aspiration during bronchoscopic procedure yielded a definitive diagnosis out of the total number of patients that have received a diagnostic procedure.
1 secondary outcome
Per-patient Diagnostic Yield
Time frame: Baseline to 12 months following procedure
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
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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. This study is not recruiting at the moment.
Sebastian Fernandez-Bussy, M.D. principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fluorescein, Image-Guided Needle Confocal Laser Endomicroscopy and Ultrasound-Guided Transbronchial Needle Aspiration in people with Lung Carcinoma, run by Mayo Clinic at 1 site in United States.
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 4 inclusion and 14 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: stopped early, as of the sponsor's last update on 17 Sep 2025. 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 United States. 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?
Yes. Results are posted in the registry (first posted 17 Sep 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
First-pass Diagnostic Yield (time frame: Baseline). 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 17 Sep 2025.