Lung Cancer, Non-Small CellNCT06739421
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
A study testing nCLE-NB-rEBUS-forcep biopsy, nCLE-NB-rEBUS-TBCB and NB-rEBUS-forcep biopsy in people with Lung Cancer, Non-Small Cell and Lung Cancer, Small Cell, run by China-Japan Friendship Hospital at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Lung Cancer, Non-Small Cell, Lung Cancer, Small Cell
- What is being tested?
- nCLE-NB-rEBUS-forcep biopsy, nCLE-NB-rEBUS-TBCB and NB-rEBUS-forcep biopsy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,040 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2025to 31 Jan 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
China-Japan Friendship Hospital, , 100029
Beijing, Beijing Municipality, 100029
Deng Mingming, MD, 18801336854, isdeng1017@163.com
About this study
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.
- Being tested
- nCLE-NB-rEBUS-forcep biopsy, nCLE-NB-rEBUS-TBCB, NB-rEBUS-forcep biopsy, NB-rEBUS-TBCB
- Keywords
- needle-based confocal laser endomicroscopy, peripheral lung cancer, peripheral lung nodules, lung biopsy
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Small Cell Lung Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nCLE-NB-rEBUS-forcep biopsyProcedure or surgery
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-TBCBProcedure or surgery
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 biopsyProcedure or surgery
The participants would undergo lung biopsy using forcep, under the guidance of navigation bronchoscopy (NB) and radial endobronchial ultrasound (rEBUS)
NB-rEBUS-TBCBProcedure or surgery
The participants would undergo transbronchial crybiopsy (TBCB), under the guidance of navigation bronchoscopy (NB) and radial endobronchial ultrasound (rEBUS)
| Study group | Role | What they receive |
|---|---|---|
| nCLE-NB-rEBUS-forcep biopsy | Experimental | 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) Receives: Procedure: nCLE-NB-rEBUS-forcep biopsy |
| nCLE-NB-rEBUS-TBCB | Experimental | 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) Receives: Procedure: nCLE-NB-rEBUS-TBCB |
| NB-rEBUS-forcep biopsy | Active comparator | The participants would undergo lung biopsy using forcep, under the guidance of navigation bronchoscopy (NB) and radial endobronchial ultrasound (rEBUS) Receives: Procedure: NB-rEBUS-forcep biopsy |
| NB-rEBUS-TBCB | Active comparator | The participants would undergo transbronchial crybiopsy (TBCB) , under the guidance of navigation bronchoscopy (NB) and radial endobronchial ultrasound (rEBUS) Receives: Procedure: NB-rEBUS-TBCB |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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 .
Measured: 7 days after the biopsy
Secondary outcomes (2)
Incidence rate of adverse events
Symptoms and signs
Measured: 7 days after the biopsy
the adequacy of sample acquisition
Samples resulting in a specific diagnosis or samples with the presence of lymphpcytes were considered as adequate.
Measured: 7 days after the biopsy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2024
- Study start1 Jan 2025 (estimated)
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung Cancer, Non-Small CellStudies of the same condition, open and under way.
- More trials run by China-Japan Friendship HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1,040 participants (estimated)
Sponsor and investigators
- Lead sponsor
- China-Japan Friendship Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gang Hou, China-Japan Friendship Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06739421
- Sponsor's protocol ID
- 2022YFC2404404-PN
- Status last verified
- Dec 2024
- First submitted
- 17 Dec 2024
- Last updated
- 18 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06739421
- Acronym / sponsor ID
- 2022YFC2404404-PN
- Keywords
- needle-based confocal laser endomicroscopy, peripheral lung cancer, peripheral lung nodules, lung biopsy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,040 participants (estimated)
- Lead sponsor
- China-Japan Friendship HospitalUniversity, hospital or other
- Study start
- 1 Jan 2025 (estimated)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Jan 2026 (estimated)
- First posted
- 18 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| nCLE-NB-rEBUS-forcep biopsy | Experimental | Procedure: nCLE-NB-rEBUS-forcep biopsyThe 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 | Experimental | Procedure: nCLE-NB-rEBUS-TBCBThe 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 comparator | Procedure: NB-rEBUS-forcep biopsyThe participants would undergo lung biopsy using forcep, under the guidance of navigation bronchoscopy (NB) and radial endobronchial ultrasound (rEBUS) |
| NB-rEBUS-TBCB | Active comparator | Procedure: NB-rEBUS-TBCBThe participants would undergo transbronchial crybiopsy (TBCB) , under the guidance of navigation bronchoscopy (NB) and radial endobronchial ultrasound (rEBUS) |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (11 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| nCLE-NB-rEBUS-forcep biopsyThe 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 or surgery | nCLE-NB-rEBUS-forcep biopsy |
| nCLE-NB-rEBUS-TBCBThe 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 or surgery | nCLE-NB-rEBUS-TBCB |
| NB-rEBUS-forcep biopsyThe participants would undergo lung biopsy using forcep, under the guidance of navigation bronchoscopy (NB) and radial endobronchial ultrasound (rEBUS) | Procedure or surgery | NB-rEBUS-forcep biopsy |
| NB-rEBUS-TBCBThe participants would undergo transbronchial crybiopsy (TBCB), under the guidance of navigation bronchoscopy (NB) and radial endobronchial ultrasound (rEBUS) | Procedure or surgery | NB-rEBUS-TBCB |
Primary outcome
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.
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 .
2 secondary outcomes
Incidence rate of adverse events
Time frame: 7 days after the biopsy
the adequacy of sample acquisition
Time frame: 7 days after the biopsy
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing nCLE-NB-rEBUS-forcep biopsy, nCLE-NB-rEBUS-TBCB and NB-rEBUS-forcep biopsy in people with Lung Cancer, Non-Small Cell and Lung Cancer, Small Cell, run by China-Japan Friendship Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 18 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hou Gang, MD (010-84205729, hougangcmu@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
diagnostic yield of lung forcep biopsy and TBCB under guidance of nCLE-NB-rEBUS (time frame: 7 days after the biopsy). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2024.