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NCT Number: NCT06739421

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

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.

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Key information

Conditions

Lung Cancer, Non-small Cell Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Cancer, Small Cell Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Small Cell Lung Carcinoma Thoracic Neoplasms

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

China-Japan Friendship Hospital, , 100029

Beijing, Beijing Municipality, 100029, China

Location contact

Deng Mingming, MD

CONTACT

[email protected]

18801336854

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

nCLE-NB-rEBUS-forcep biopsy

Procedure

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

Procedure

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

Procedure

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

NB-rEBUS-TBCB

Procedure

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

Primary outcomes

  1. diagnostic yield of lung forcep biopsy and TBCB under guidance of nCLE-NB-rEBUS

    Time frame: 7 days after the biopsy

    The proportion of participants in whom the biopsy led to a definitive diagnosis.

  2. Sensitivity of lung forcep biopsy and TBCB under guidance of nCLE-NB-rEBUS

    Time frame: 7 days after the biopsy

    The proportion of participants of lung cancer in whom the biopsy led to a definitive diagnosis .

Secondary outcomes

  1. Incidence rate of adverse events

    Time frame: 7 days after the biopsy

    Symptoms and signs

  2. the adequacy of sample acquisition

    Time frame: 7 days after the biopsy

    Samples resulting in a specific diagnosis or samples with the presence of lymphpcytes were considered as adequate.

Study contacts

Contact information is provided by the study sponsor or research team.

Deng Mingming, MD

CONTACT

[email protected]

18801336854

Hou Gang, MD

CONTACT

[email protected]

010-84205729

Sponsors and collaborators

Lead sponsor

China-Japan Friendship Hospital

Other

Registry information

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Dec 18, 2024
Registry last updated
Dec 18, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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