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New laser imaging aims to spot lung cancer in real time

NCT ID NCT05556525

Diagnosis Sponsor: Mayo Clinic Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 Results may not be published yet.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 This study
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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 26, 2026 · Updated 1 time

Summary

This study tested whether adding a special laser imaging technique (nCLE) and a dye (fluorescein) to a standard needle biopsy could help doctors diagnose lung cancer more accurately. The plan was to compare the combined approach to the standard biopsy alone in people with suspicious lung nodules. However, the trial was stopped early after enrolling only 3 participants, so it did not produce meaningful results.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Fluorescein
What this could lead to
If successful, this approach could improve the accuracy of lung cancer diagnosis during a single procedure, reducing the need for repeat biopsies.
What could go wrong
The trial was terminated early with only 3 participants, so no reliable conclusions can be drawn. The technique is still experimental and may not work better than standard methods.

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

3 people

The number who actually took part.

Started

May 2023

Finished

Oct 2024

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

21 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: * \>= 21 years of age * Suspected PPN * Nodule size in computed tomography (CT) between 8 mm and 30 mm (largest dimension) * Ability to understand and willingness to sign a written informed consent and Health Insurance Portability and Accountability Act (HIPAA) consent document Exclusion Criteria: * Inability or non-willingness to provide informed consent * Failure to comply with the study protocol * Patients with known allergy for fluorescein or risk factors for an allergic reaction * Use of beta-blocker within 24 hours before the start of the bronchoscopic procedure * Possibly pregnant, pregnant or breastfeeding women * Patients with hemodynamic instability * Patients with refractory hypoxemia * Patients with a therapeutic anticoagulant that cannot be held for an appropriate interval before the procedure * Patients who are unable to tolerate general anesthesia according to the anesthesiologist * Patient undergoing chemotherapy * INTRA-OPERATIVE EXCLUSION/STOPPING CRITERIA: * The lesions are unable to be localized/confirmed by bronchoscopy * The procedure will be terminated if the patient develops a significant procedural complication as determined by the treating physician * The procedure will be terminated if the patient develops hemodynamic instability as determined by the treating physician

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Conditions

The condition(s) this trial relates to.

lung cancer lung carcinoma lung neoplasm

As listed by the trial registrant

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

Lung carcinoma

Contacts and locations

Locations

  • Mayo Clinic in Florida

    Jacksonville, Florida, 32224-9980, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.