NCT06739421Not yet recruiting
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
Source: ClinicalTrials.gov · Last updated 18 Dec 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 1040 (estimated)
- First submitted
- 17 Dec 2024
- Start date
- 1 Jan 2025
- Primary completion date
- 31 Dec 2025
- Lead sponsor
- China-Japan Friendship Hospital
- Diseases
- Lung cancer
- NCT number
- NCT06739421
What you commit to
- Study type: Interventional
- Planned participants: 1040
- From 1 Jan 2025 to the primary completion date, 31 Dec 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Undergoing chemotherapy as several chemotherapies have fluorescent properties at the same wavelength (eg, doxorubicin).
Other illness
- Endobronchial visible malignancy on bronchoscopic inspection;
- Failure to comply with the study protocol;
- Known allergy or risk factors for an allergic reaction to fluorescein;
Other
- Inability or non-willingness to provide informed consent;
- Target lesion within reach of the linear EBUS scope;
- 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;
Who the study is looking for
- 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.
Age in the registry: 18 years to 90 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| China-Japan Friendship Hospital, , 100029 Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.