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
1 other identifier
interventional
1,040
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2025
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 17, 2024
CompletedFirst Posted
Study publicly available on registry
December 18, 2024
CompletedStudy Start
First participant enrolled
January 1, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
January 31, 2026
CompletedDecember 18, 2024
December 1, 2024
12 months
December 17, 2024
December 17, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
diagnostic yield of lung forcep biopsy and TBCB under guidance of nCLE-NB-rEBUS
The proportion of participants in whom the biopsy led to a definitive diagnosis.
7 days after the biopsy
Sensitivity of lung forcep biopsy and TBCB under guidance of nCLE-NB-rEBUS
The proportion of participants of lung cancer in whom the biopsy led to a definitive diagnosis .
7 days after the biopsy
Secondary Outcomes (2)
Incidence rate of adverse events
7 days after the biopsy
the adequacy of sample acquisition
7 days after the biopsy
Study Arms (4)
nCLE-NB-rEBUS-forcep biopsy
EXPERIMENTALThe participants would undergo lung biopsy using forcep, under the guidance of bronchoscopic needle-based confocal laser endomicroscopy (nCLE) with the assistance of navigation bronchoscopy (NB) and radial endobronchial ultrasound (rEBUS)
nCLE-NB-rEBUS-TBCB
EXPERIMENTALThe participants would undergo transbronchial crybiopsy (TBCB) , under the guidance of bronchoscopic needle-based confocal laser endomicroscopy (nCLE) with the assistance of navigation bronchoscopy (NB) and radial endobronchial ultrasound (rEBUS)
NB-rEBUS-forcep biopsy
ACTIVE COMPARATORThe participants would undergo lung biopsy using forcep, under the guidance of navigation bronchoscopy (NB) and radial endobronchial ultrasound (rEBUS)
NB-rEBUS-TBCB
ACTIVE COMPARATORThe participants would undergo transbronchial crybiopsy (TBCB) , under the guidance of navigation bronchoscopy (NB) and radial endobronchial ultrasound (rEBUS)
Interventions
The participants would undergo lung biopsy using forcep, under the guidance of bronchoscopic needle-based confocal laser endomicroscopy (nCLE) with the assistance of navigation bronchoscopy (NB) and radial endobronchial ultrasound (rEBUS)
The participants would undergo transbronchial crybiopsy (TBCB), under the guidance of bronchoscopic needle-based confocal laser endomicroscopy (nCLE) with the assistance of navigation bronchoscopy (NB) and radial endobronchial ultrasound (rEBUS)
The participants would undergo lung biopsy using forcep, under the guidance of navigation bronchoscopy (NB) and radial endobronchial ultrasound (rEBUS)
The participants would undergo transbronchial crybiopsy (TBCB), under the guidance of navigation bronchoscopy (NB) and radial endobronchial ultrasound (rEBUS)
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
China-Japan Friendship Hospital, , 100029
Beijing, Beijing Municipality, 100029, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
December 17, 2024
First Posted
December 18, 2024
Study Start
January 1, 2025
Primary Completion
December 31, 2025
Study Completion
January 31, 2026
Last Updated
December 18, 2024
Record last verified: 2024-12