Can a laser microscope match the gold standard for spotting lung cancer during a biopsy?
NCT ID NCT07725510
First seen Jul 24, 2026 · Last updated Jul 24, 2026
Summary
This study compares two methods for quickly analyzing lung tissue samples during a bronchoscopy: confocal laser endomicroscopy (CLE), which uses a laser to scan the tissue, and rapid on-site evaluation (ROSE), where a cytologist examines cells under a microscope. The goal is to see if CLE can accurately detect cancer in small lung lesions without destroying the tissue, potentially replacing ROSE. Thirty participants with suspicious lung nodules will have their biopsy samples analyzed by both methods, and the results will be checked against the final lab diagnosis.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- What this could lead to
- If CLE proves as accurate as ROSE, it could offer a non-consumptive, real-time diagnostic method for lung biopsies, potentially speeding up diagnosis and preserving tissue for further testing.
- What could go wrong
- This is a small, early-stage study with only 30 participants, so results may not generalize. CLE requires specialized equipment and expertise, which could limit its widespread use.
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Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 30 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jun 2026
- Expected to finish
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Dec 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
This study will enroll 60 adult participants with newly identified peripheral pulmonary lesions (PPLs) who are scheduled to undergo diagnostic navigational bronchoscopy. The target population consists of patients presenting with solitary or multiple pulmonary nodules or masses ranging from 5 to 50 mm in maximum diameter on computed tomography (CT) imaging, who have a clinical indication for tissue diagnosis. All participants must be surgical candidates fit enough to tolerate flexible bronchoscopy and meet standard pre-procedural coagulation parameters. Pregnant or lactating women, as well as individuals with severe cardiopulmonary insufficiency or uncorrectable coagulopathy, will be excluded to ensure procedural safety. Written informed consent will be obtained from all participants prior to enrollment. The study population is specifically selected to evaluate the diagnostic efficacy of novel optical biopsy (CLE) against the current standard (ROSE) in lesions where tissue acquisition
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * （1）Imaging Findings: Presence of a peripheral pulmonary lesion (PPL) measuring 5 to 50 mm in maximum diameter on chest CT scan. （2）Clinical Indication: Patients with a clinical indication for diagnostic flexible bronchoscopy and transbronchial biopsy. （3）Consent: Provision of signed and dated written informed consent prior to any study-specific procedures. Exclusion Criteria: * （1）Contraindications to Bronchoscopy: Patients with severe cardiopulmonary insufficiency or any absolute contraindication to flexible bronchoscopy (e.g., severe hypoxemia, unstable angina, or uncontrolled asthma). （2）Coagulopathy: Patients with severe coagulation disorders (e.g., platelets \<50,000/μL, INR \>1.5) not corrected prior to the procedure. （3）Pregnancy/Lactation: Pregnant or lactating women.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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The First Affiliated Hospital of Guangzhou Medical University, Guangzhou, Guangdong 510163
RECRUITINGGuangzhou, Guangdong, 510100, China
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