Peripheral Pulmonary LesionsNCT07827326
Clinical Utility of Needle-Based Confocal Laser Endomicroscopy for Peripheral Pulmonary Lesions
An observational study of Peripheral Pulmonary Lesions, run by First Affiliated Hospital of Ningbo University at 3 sites in China.
Trial summary
This prospective, multicenter diagnostic accuracy study will evaluate the clinical utility of needle-based confocal laser endomicroscopy (nCLE) for differentiating malignant from benign peripheral pulmonary lesions (PPLs). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral Pulmonary Lesions
- What is being tested?
- Confocal Laser Endomicroscopy
- Type of treatment
- Injection or infusion, Medical device
- How many people
- 100 participants
- Where
- 3 sitesChina
- Study dates
- 1 Oct 2026to 31 Oct 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: The study population will consist of adults aged 18 years or older with peripheral pulmonary lesions detected on chest computed tomography who are referred to the respiratory endoscopy units of three participating tertiary hospitals in China for clinically indicated diagnostic bronchoscopy and tissue sampling. Eligible patients will be prospectively screened and invited to participate. Participants must be willing to undergo radial probe endobronchial ultrasound localization and needle-based confocal laser endomicroscopy and must provide written informed consent. Patients with lesions ultimately diagnosed as either malignant or benign will be included.
Who may be able to join
- Age 18 years or older.
- A peripheral pulmonary lesion identified on chest CT.
- Bronchoscopic biopsy considered clinically necessary by the treating physician to establish a pathologic diagnosis.
- Willingness to undergo r-EBUS and nCLE examinations.
- Voluntary participation with written informed consent.
Who cannot join
- A contraindication to bronchoscopy, including severe cardiopulmonary disease,coagulation disorder, failure to discontinue anticoagulant therapy or anticoagulant medication for at least 5 days before the procedure, poor tolerance of anesthesia,psychiatric illness, or severe neurosis.
- Pregnancy or breastfeeding.
- Known allergy to fluorescein sodium.
- Coagulation disorder.
- A known allergic disorder, history of asthma, hepatic failure, renal failure, or another contraindication to fluorescein sodium injection.
- Continued use of a systemic beta-blocker on the day of the procedure, or inability to discontinue the beta-blocker safely as assessed by the investigator and anesthesiologist.
- Inability to cooperate with the study for any reason, or any other condition that the investigator considers unsuitable for enrollment.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China3 sites
Anhui Chest Hospital
Hefei, Hefei, 230022
Fei Tang, +86-13505696936, tangfei1205@163.com
Shanghai Chest Hospital
Shanghai, Shanghai Municipality, 200030
Jiayuan Sun, +86-18017321598, jysun1976@163.com
The First Affiliated Hospital of Ningbo University
Zhejiang, Ningbo, 315000
ZHongbo Chen, +86-13777125910, leonczb@163.com
About this study
This prospective, multicenter diagnostic accuracy study will evaluate the clinical utility of needle-based confocal laser endomicroscopy (nCLE) for differentiating malignant from benign peripheral pulmonary lesions (PPLs). A total of 100 participants undergoing bronchoscopic evaluation of PPLs will be enrolled at three hospitals in China.
Following successful lesion localization using radial endobronchial ultrasound, nCLE imaging will be performed after intravenous administration of fluorescein, followed by standard bronchoscopic tissue sampling. nCLE findings will be compared with the final diagnosis established by histopathology, surgical pathology, or six-month clinical and imaging follow-up when necessary.
The primary outcomes are the sensitivity, specificity, positive predictive value, negative predictive value, and overall diagnostic accuracy of nCLE. Procedure duration and procedure-related adverse events will also be recorded. The investigators hypothesize that nCLE can accurately distinguish malignant from benign PPLs in real time.
- Conditions
- Peripheral Pulmonary Lesions
- Being tested
- Confocal Laser Endomicroscopy
- Keywords
- Peripheral Pulmonary Lesions, Bronchoscopy, Confocal Laser Endomicroscopy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Confocal Laser EndomicroscopyDevice
After successful localization of the peripheral pulmonary lesion using radial probe endobronchial ultrasound, a needle-based confocal laser endomicroscopy probe will be advanced through the same guide sheath. Following intravenous administration of 200 mg fluorescein sodium diluted in 8 mL of normal saline, the probe will be placed in gentle contact with the target lesion to acquire real-time microscopic images. A 1.4-mm probe will be used whenever feasible; a 0.8-mm probe may be used when the larger probe cannot pass through the working channel or guide sheath. The probe position may be adjusted to obtain diagnostically meaningful images. Images will be recorded before bronchoscopic tissue sampling and subsequently evaluated using predefined criteria for malignant and benign lesions. The nCLE findings will be compared with the final diagnosis established by histopathology and follow-up when necessary.
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic Accuracy of Needle-Based Confocal Laser Endomicroscopy for Differentiating Malignant From Benign Peripheral Pulmonary Lesions
Measured: Up to 6 months after the index bronchoscopy
Secondary outcomes (2)
Incidence and Severity of Procedure-Related Adverse Events
Measured: Periprocedural
Duration of the nCLE Procedure
Measured: Periprocedural
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2026
- Study start1 Oct 2026 (estimated)
- Primary completion31 Oct 2027 (estimated)
- Study completion31 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Pulmonary LesionsStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- First Affiliated Hospital of Ningbo University
- Sponsor type
- Research network
- Collaborators
- Shanghai Chest Hospital, Anhui Chest Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07827326
- Sponsor's protocol ID
- 2026-R324-01
- Status last verified
- Sep 2026
- First submitted
- 14 Sep 2026
- Last updated
- 21 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Utility of Needle-Based Confocal Laser Endomicroscopy for Peripheral Pulmonary Lesions
- ClinicalTrials.gov ID
- NCT07827326
- Acronym / sponsor ID
- 2026-R324-01
- Conditions
- Peripheral Pulmonary Lesions
- Keywords
- Peripheral Pulmonary Lesions, Bronchoscopy, Confocal Laser Endomicroscopy
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- First Affiliated Hospital of Ningbo UniversityResearch network
- Collaborators
- Shanghai Chest Hospital, Anhui Chest Hospital
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 31 Oct 2027 (estimated)
- Study completion
- 31 Oct 2027 (estimated)
- First posted
- 18 Sep 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.
This prospective, multicenter diagnostic accuracy study will evaluate the clinical utility of needle-based confocal laser endomicroscopy (nCLE) for differentiating malignant from benign peripheral pulmonary lesions (PPLs). A total of 100 participants undergoing bronchoscopic evaluation of PPLs will be enrolled at three hospitals in China.
Following successful lesion localization using radial endobronchial ultrasound, nCLE imaging will be performed after intravenous administration of fluorescein, followed by standard bronchoscopic tissue sampling. nCLE findings will be compared with the final diagnosis established by histopathology, surgical pathology, or six-month clinical and imaging follow-up when necessary.
The primary outcomes are the sensitivity, specificity, positive predictive value, negative predictive value, and overall diagnostic accuracy of nCLE. Procedure duration and procedure-related adverse events will also be recorded. The investigators hypothesize that nCLE can accurately distinguish malignant from benign PPLs in real time.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will consist of adults aged 18 years or older with peripheral pulmonary lesions detected on chest computed tomography who are referred to the respiratory endoscopy units of three participating tertiary hospitals in China for clinically indicated diagnostic bronchoscopy and tissue sampling. Eligible patients will be prospectively screened and invited to participate. Participants must be willing to undergo radial probe endobronchial ultrasound localization and needle-based confocal laser endomicroscopy and must provide written informed consent. Patients with lesions ultimately diagnosed as either malignant or benign will be included.
Key inclusion criteria (5 listed)
- Age 18 years or older.
- A peripheral pulmonary lesion identified on chest CT.
- Bronchoscopic biopsy considered clinically necessary by the treating physician to establish a pathologic diagnosis.
- Willingness to undergo r-EBUS and nCLE examinations.
- Voluntary participation with written informed consent.
Key exclusion criteria (7 listed)
- A contraindication to bronchoscopy, including severe cardiopulmonary disease,coagulation disorder, failure to discontinue anticoagulant therapy or anticoagulant medication for at least 5 days before the procedure, poor tolerance of anesthesia,psychiatric illness, or severe neurosis.
- Pregnancy or breastfeeding.
- Known allergy to fluorescein sodium.
- Coagulation disorder.
- A known allergic disorder, history of asthma, hepatic failure, renal failure, or another contraindication to fluorescein sodium injection.
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 |
|---|---|---|
| Confocal Laser EndomicroscopyAfter successful localization of the peripheral pulmonary lesion using radial probe endobronchial ultrasound, a needle-based confocal laser endomicroscopy probe will be advanced through the same guide sheath. Following intravenous administration of 200 mg fluorescein sodium diluted in 8 mL of normal saline, the probe will be placed in gentle contact with the target lesion to acquire real-time microscopic images. A 1.4-mm probe will be used whenever feasible; a 0.8-mm probe may be used when the larger probe cannot pass through the working channel or guide sheath. The probe position may be adjusted to obtain diagnostically meaningful images. Images will be recorded before bronchoscopic tissue sampling and subsequently evaluated using predefined criteria for malignant and benign lesions. The nCLE findings will be compared with the final diagnosis established by histopathology and follow-up when necessary. | Device | – |
Primary outcome
Diagnostic Accuracy of Needle-Based Confocal Laser Endomicroscopy for Differentiating Malignant From Benign Peripheral Pulmonary Lesions
Time frame: Up to 6 months after the index bronchoscopy
2 secondary outcomes
Incidence and Severity of Procedure-Related Adverse Events
Time frame: Periprocedural
Duration of the nCLE Procedure
Time frame: Periprocedural
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 21 Sep 2026.
- Individual participant dataSharing planned: Yes
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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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Peripheral Pulmonary Lesions, run by First Affiliated Hospital of Ningbo University at 3 sites in China.
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 7 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 21 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 3 sites in China. 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 Zhongbo Chen (86+13777125910, leonczb@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic Accuracy of Needle-Based Confocal Laser Endomicroscopy for Differentiating Malignant From Benign Peripheral Pulmonary Lesions (time frame: Up to 6 months after the index bronchoscopy). 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 21 Sep 2026.