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Clinical Trials in Japan / NCT06739421
Starting soon Not 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

NCT06739421 · tracked via the Priya Life Science Japan tracker
Sponsor
China-Japan Friendship Hospital
Phase
Not applicable
Started
2025-01-01
Last updated
2024-12-18

Condition(s) studied

Lung Cancer, Non-Small CellLung Cancer, Small Cell

Investigational drug(s) / intervention(s)

nCLE-NB-rEBUS-forcep biopsynCLE-NB-rEBUS-TBCBNB-rEBUS-forcep biopsyNB-rEBUS-TBCB

nCLE-NB-rEBUS-forcep biopsy: 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)

nCLE-NB-rEBUS-TBCB: 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)

NB-rEBUS-forcep biopsy: The participants would undergo lung biopsy using forcep, under the guidance of navigation bronchoscopy (NB) and radial endobronchial ultrasound (rEBUS)

NB-rEBUS-TBCB: The participants would undergo transbronchial crybiopsy (TBCB), under the guidance of navigation bronchoscopy (NB) and radial endobronchial ultrasound (rEBUS)

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
90 Years
Healthy volunteers
No
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).

Primary outcome measure(s)

  • diagnostic yield of lung forcep biopsy and TBCB under guidance of nCLE-NB-rEBUS — 7 days after the biopsy
    The proportion of participants in whom the biopsy led to a definitive diagnosis.
  • Sensitivity of lung forcep biopsy and TBCB under guidance of nCLE-NB-rEBUS — 7 days after the biopsy
    The proportion of participants of lung cancer in whom the biopsy led to a definitive diagnosis .

Trial sites (1)

FacilityCityRegionStatus
China-Japan Friendship Hospital, , 100029 Beijing Beijing Municipality

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06739421 on ClinicalTrials.gov ↗ ← All trials in Japan