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Can a scanner instantly tell if a lung biopsy is good enough?

NCT ID NCT05393154

Diagnosis Sponsor: Aquyre Bioscience, Inc 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 18, 2026 · Last updated Aug 19, 2026 · Updated 1 time

Summary

This study tests a new scanner that uses light-based imaging to quickly check whether small lung tissue samples taken during a bronchoscopy are adequate for diagnosis. The goal is to see if the scanner can accurately tell apart samples that are usable from those that aren't, compared to standard pathology. If it works, it could help doctors avoid repeat procedures and speed up lung cancer diagnosis.

What this could mean

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

Active substance
Aquyre Biopsy Scanner (a device using optical coherence tomography and dynamic cell imaging to view biopsy samples)
What this could lead to
If successful, this scanner could help doctors quickly know if a biopsy sample is usable, reducing repeat procedures and speeding up lung cancer diagnosis.
What could go wrong
This is a small pilot study, so the scanner's accuracy is not yet proven. It may not reliably match pathology results, and its performance could vary in real-world use.

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

55 people

The number who actually took part.

Started

Sep 2021

Finished

Aug 2024

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Tissue will be collected from patients with radiographically identified lung lesions suspicious for cancer for whom a biopsy is being performed for pathological diagnosis, as determined by the investigator.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

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. Signed informed consent prior to initiation of any study procedures. 2. Patient has a radiographically identified lung lesion(s) suspicious for malignancy and requiring histopathologic diagnosis. 3. Patient with a previously obtained (within 3 months) CT image showing at least one solid lesion equal to or greater than 1 cm in diameter or at least one semisolid lesion with a solid component of equal to or greater than 1 cm in diameter. 4. Bronchoscopic biopsy procedure is planned for the above lesion(s). Exclusion Criteria: 1. Patient does not meet the requirements to undergo biopsy as determined by the treating physician. 2. Patient is unable to provide a signed informed consent to participate in the study. 3. Patient has only ground glass lesion(s) that do not have a solid component.

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Conditions

The condition(s) this trial relates to.

lung cancer lung neoplasm

As listed by the trial registrant

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

Lung cancer

Contacts and locations

Locations

  • Boston Medical Center

    Boston, Massachusetts, 02118, United States

More trials for these conditions

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