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New laser microscope could boost lung cancer detection during bronchoscopy

NCT ID NCT06079970

Diagnosis Sponsor: Amsterdam University Medical Centers (UMC), Location Academic Medical Center (AMC) Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study compares standard bronchoscopy (using a thin tube to look at the lungs) with and without an additional laser-based microscope called nCLE. The microscope helps doctors see if the sampling needle is in the right spot before taking tissue. About 208 adults with suspicious lung nodules will take part. The goal is to see if nCLE leads to more accurate diagnoses.

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 (nCLE) device
What this could lead to
If successful, this could make lung nodule diagnosis more accurate, reducing the need for repeat procedures or more invasive biopsies.
What could go wrong
This is a relatively small, early-stage trial (208 participants) comparing a new imaging technique to standard care. The improvement in diagnosis may be modest, and the device adds complexity and cost.

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.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 208 people

The number the study aims to enrol. It can still change while the study runs.

Started

Oct 2023

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

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.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

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

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. ≥18 years of age 2. Suspected malignant peripheral lung lesion with an indication for a bronchoscopic diagnostic work-up as determined by the attending physician or tumor board. Peripheral pulmonary lesions are defined as lesions located beyond the visible segmental bronchi, not detectable by regular flexible bronchoscopy 3. Bronchus sign on pre-procedural CT or estimated confidence for successful navigation to the nodule resulting in a r-EBUS signal 4. Solid part of the lesion must be ≧10 mm 5. Largest dimension of lesion size on CT ≦30 mm (long-axis) 6. Ability to understand and willingness to sign a written informed consent Exclusion Criteria: 1. Inability or non-willingness to provide informed consent 2. Endobronchial visible malignancy on bronchoscopic inspection 3. Target lesion within reach of the linear EBUS scope 4. Failure to comply with the study protocol 5. Known allergy or risk factors for an allergic reaction to fluorescein 6. Pregnancy or breastfeeding 7. Hemodynamic instability 8. Refractory hypoxemia 9. Therapeutic anticoagulant use that cannot be withheld for an appropriate interval before the procedure 10. Unable to tolerate general anesthesia according to the anesthesiologist 11. Undergoing chemotherapy as several chemotherapies have fluorescent properties at the same wavelength (e.g., doxorubicin)

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Conditions

The condition(s) this trial relates to.

lung cancer lung neoplasm non-small cell lung carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Carcinoma, non-small-cell lung Lung cancer Lung neoplasm malignant Neoplasm of lung

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    5 sites in 5 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • Amsterdam University Medical Centers

    RECRUITING

    Amsterdam, 1081 HV, Netherlands

  • General University Hospital Prague

    RECRUITING

    Prague, Czechia

  • Montefiore Medical Center

    RECRUITING

    New York, New York, 10467, United States

  • Sotiria Hospital

    RECRUITING

    Athens, Greece

  • Vienna General Hospital

    RECRUITING

    Vienna, Austria

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