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

December 17, 2024 updated by: Gang Hou, China-Japan Friendship Hospital

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

1040

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100029
        • China-Japan Friendship Hospital, , 100029
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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)
Procedure: 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)
Experimental: 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)
Procedure: 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)
Active Comparator: NB-rEBUS-forcep biopsy
The participants would undergo lung biopsy using forcep, under the guidance of navigation bronchoscopy (NB) and radial endobronchial ultrasound (rEBUS)
Procedure: NB-rEBUS-forcep biopsy
The participants would undergo lung biopsy using forcep, under the guidance of navigation bronchoscopy (NB) and radial endobronchial ultrasound (rEBUS)
Active Comparator: NB-rEBUS-TBCB
The participants would undergo transbronchial crybiopsy (TBCB) , under the guidance of navigation bronchoscopy (NB) and radial endobronchial ultrasound (rEBUS)
Procedure: NB-rEBUS-TBCB
The participants would undergo transbronchial crybiopsy (TBCB), under the guidance of navigation bronchoscopy (NB) and radial endobronchial ultrasound (rEBUS)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
7 days after the biopsy
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 .
7 days after the biopsy

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence rate of adverse events
Time Frame: 7 days after the biopsy
Symptoms and signs
7 days after the biopsy
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.
7 days after the biopsy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

China-Japan Friendship Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 1, 2025

Primary Completion (Estimated)

December 31, 2025

Study Completion (Estimated)

January 31, 2026

Study Registration Dates

First Submitted

December 17, 2024

First Submitted That Met QC Criteria

December 17, 2024

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

December 17, 2024

Last Verified

December 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2022YFC2404404-PN

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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