The Diagnostic Value of Bronchoscopic Needle-based Confocal Laser Endomicroscopy (nCLE) As a Real… (NCT06739421) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
The Diagnostic Value of Bronchoscopic Needle-based Confocal Laser Endomicroscopy (nCLE) As a Real-time Detection Tool for Diagnosing Peripheral Lung Cancer: a Multi-centre Randomised Controlled Trial
China1,040 participantsStarted 2025-01-01
Plain-language summary
The goal of this prospective, multi-centre, randomised controlled clinical study is to evaluate the diagnostic efficacy and safety of nCLE guided lung biopsy in patients with for peripheral lung nodules under the assistance of navigation bronchoscopy (NB) and radial endobronchial ultrasound (rEBUS), and assess whether the biopsy techniques, namely transbronchial crybiopsy (TBCB) and transbronchial forceps biopsy (TBFB), would influence the diagnostic efficacy and safety of nCLE guided biopsy.
Participants will divided into nCLE-NB-rEBUS-forcep biopsy group, nCLE-NB-rEBUS-TBCB group, NB-rEBUS-forcep biopsy group, and NB-rEBUS-TBCB group at a 1:1:1:1 ratio by using central, computerized random sequence, and then undertake nCLE-NB-rEBUS-forcep biopsy, nCLE-NB-rEBUS-TBCB, NB-rEBUS-forcep biopsy, and NB-rEBUS-TBCB according to the group.
Researchers will compare the diagnostic yield and incidence of adverse events of the four biopsy techniques.
Who can participate
Age range
18 Years – 90 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* patients with peripheral lung nodules suspected of lung cancer based on CT scan (10mm≤size\<30mm);
* patients requiring diagnostic bronchoscopy procedure to determine the benign or malignant nature of the lung nodule;
* Patients who can understand the purpose of the trial, participate voluntarily and sign an informed consent form.
Exclusion Criteria:
* Inability or non-willingness to provide informed consent;
* Endobronchial visible malignancy on bronchoscopic inspection;
* Target lesion within reach of the linear EBUS scope;
* Failure to comply with the study protocol;
* Known allergy or risk factors for an allergic reaction to fluorescein;
* Pregnancy or breast feeding;
* Haemodynamic instability;
* Refractory hypoxaemia;
* Therapeutic anticoagulant use that cannot be withheld for an appropriate interval before the procedure;
* Unable to tolerate general anaesthesia according to the anaesthesiologist;
* Undergoing chemotherapy as several chemotherapies have fluorescent properties at the same wavelength (eg, doxorubicin).
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
diagnostic yield of lung forcep biopsy and TBCB under guidance of nCLE-NB-rEBUS
Timeframe: 7 days after the biopsy
2
Sensitivity of lung forcep biopsy and TBCB under guidance of nCLE-NB-rEBUS