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Tiny probe aims to give Real-Time cancer answers for lung spots
NCT ID NCT07827326
First seen Sep 18, 2026 · Last updated Sep 21, 2026 · Updated 1 time
Summary
Researchers are testing a needle-based confocal laser endomicroscopy (nCLE) probe to see if it can tell malignant from benign peripheral pulmonary lesions during a bronchoscopy. One hundred adults with a lung lesion seen on CT will receive a fluorescent dye and then have the tiny probe placed against the lesion to capture microscopic images. Doctors will compare those images to the final diagnosis from tissue samples or follow-up scans to measure how accurate the probe is.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- needle-based confocal laser endomicroscopy with fluorescein dye
- What this could lead to
- If it works, doctors could get an immediate answer about whether a lung spot is cancer during a bronchoscopy, possibly reducing the need for repeat procedures or waiting days for lab results.
- What could go wrong
- This is a diagnostic accuracy study, not a treatment trial, and it may show the microscope images are not reliable enough to replace standard tissue biopsy. The procedure also requires intravenous dye and inserting a probe deep into the lung, which carries small risks of bleeding or infection.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 100 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Oct 2026
An estimate. Start dates often move.
- Expected to finish
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Oct 2027
An estimate. End dates often move.
- Lead sponsor
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A research network
The lead sponsor is a research network or cooperative group.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
The study population will consist of adults aged 18 years or older with peripheral pulmonary lesions detected on chest computed tomography who are referred to the respiratory endoscopy units of three participating tertiary hospitals in China for clinically indicated diagnostic bronchoscopy and tissue sampling. Eligible patients will be prospectively screened and invited to participate. Participants must be willing to undergo radial probe endobronchial ultrasound localization and needle-based confocal laser endomicroscopy and must provide written informed consent. Patients with lesions ultimately diagnosed as either malignant or benign will be included.
- 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: * Age 18 years or older. * A peripheral pulmonary lesion identified on chest CT. * Bronchoscopic biopsy considered clinically necessary by the treating physician to establish a pathologic diagnosis. * Willingness to undergo r-EBUS and nCLE examinations. * Voluntary participation with written informed consent. Exclusion Criteria: * A contraindication to bronchoscopy, including severe cardiopulmonary disease,coagulation disorder, failure to discontinue anticoagulant therapy or anticoagulant medication for at least 5 days before the procedure, poor tolerance of anesthesia,psychiatric illness, or severe neurosis. * Pregnancy or breastfeeding. * Known allergy to fluorescein sodium. * Coagulation disorder. * A known allergic disorder, history of asthma, hepatic failure, renal failure, or another contraindication to fluorescein sodium injection. * Continued use of a systemic beta-blocker on the day of the procedure, or inability to discontinue the beta-blocker safely as assessed by the investigator and anesthesiologist. * Inability to cooperate with the study for any reason, or any other condition that the investigator considers unsuitable for enrollment.
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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
3 sites. 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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Anhui Chest Hospital
Hefei, Hefei, 230022, China
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Shanghai Chest Hospital
Shanghai, Shanghai Municipality, 200030, China
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The First Affiliated Hospital of Ningbo University
Zhejiang, Ningbo, 315000, China