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Laser and AI team up to spot lung cancer in minutes during surgery

NCT ID NCT07681245

Diagnosis Sponsor: Shanghai Chest Hospital 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 02, 2026 · Last updated Sep 04, 2026 · Updated 3 times

Summary

This trial investigates whether a femtosecond laser combined with an artificial intelligence model can diagnose lung cancer from fresh tissue samples as accurately as the standard frozen section method. About 294 adults scheduled for lung surgery will have their tumor specimens examined both ways, and results will be compared to the final lab analysis. If the laser-AI approach proves non-inferior, it could offer a faster, label-free diagnostic option during surgery.

What this could mean

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

Active substance
femtosecond laser imaging with artificial intelligence
What this could lead to
If successful, this could provide a faster, non-destructive way to diagnose lung cancer during surgery, reducing wait times for patients.
What could go wrong
This is an early-stage comparison study; the AI may not match the accuracy of standard pathology, and results are not yet used to guide treatment decisions.

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

About 294 people

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

Started

Jul 2026

Expected to finish

Nov 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.

Who is studied

The study population will consist of patients with pulmonary nodules, pulmonary space-occupying lesions, or suspected pulmonary tumor lesions who are scheduled to undergo surgical resection at participating centers. Eligible patients will require intraoperative pathological assessment, and fresh lung tissue specimens must be available for both femtosecond laser imaging and standard frozen section diagnosis. All participants will be prospectively enrolled according to the predefined inclusion and exclusion criteria, and the diagnostic results will be compared with the final paraffin-embedded pathological diagnosis as the reference standard.

Ages

18 to 90 years

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. Preoperative imaging suggests a pulmonary nodule, pulmonary space-occupying lesion, or suspected pulmonary tumor lesion. 2. The participant is scheduled to undergo pulmonary wedge resection, segmentectomy, lobectomy, or other pulmonary surgery. 3. Fresh lung tissue specimens can be obtained intraoperatively for femtosecond laser imaging. 4. Intraoperative frozen section diagnosis is planned to assess the nature of the tumor lesion. 5. Corresponding postoperative paraffin-embedded pathological diagnosis can be obtained. 6. The participant or the participant's legally authorized representative has signed the written informed consent form. 7. Patients had not received any antitumor treatment prior to enrollment or specimen collection, including chemotherapy, radiotherapy, targeted therapy, immunotherapy, or other systemic anticancer treatments. Exclusion Criteria: 1. The intraoperative specimen is insufficient and cannot simultaneously meet the requirements for routine clinical pathological diagnosis and research-related testing. 2. The specimen shows severe carbonization, necrosis, compression, contamination, or improper preservation, and the investigator determines that effective imaging cannot be completed. 3. The femtosecond laser imaging specimen cannot be matched with the corresponding lesion assessed by final paraffin pathology. 4. Final paraffin-embedded pathological diagnosis cannot be obtained. 5. The participant withdraws informed consent. 6. Other conditions that, in the opinion of the investigator, make the participant unsuitable for this study.

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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

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. 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

  • Dongfang Hospital

    NOT_YET_RECRUITING

    Shanghai, Shanghai Municipality, 200030, China

  • Huadong Hospital

    NOT_YET_RECRUITING

    Shanghai, Shanghai Municipality, 200030, China

  • Shanghai Chest Hospital

    RECRUITING

    Shanghai, Shanghai Municipality, 200030, China

  • Tongji Hospital

    NOT_YET_RECRUITING

    Shanghai, Shanghai Municipality, 200030, China

  • Tongren Hospital

    NOT_YET_RECRUITING

    Shanghai, Shanghai Municipality, 200030, China

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