ClinicalTrials.gg
Not yet recruitingNCT07794449Updated Aug 31, 2026

A Multicenter, Prospective Study on the Diagnostic Efficacy of Femtosecond Laser Label-Free Imaging Combined With Artificial Intelligence-Assisted Diagnosis for Rapid Diagnosis of Lung Cancer Surgical Specimens

An observational study in Lung Cancer (Diagnosis), sponsored by Shanghai Zhongshan Hospital. Not yet recruiting. Per ClinicalTrials.gov, last updated 2026-08-31.

Sponsored by Shanghai Zhongshan Hospital · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
335
Sex
All
01

Study summary

To investigate the diagnostic efficacy of Femtosecond Laser Label-Free Imaging combined with artificial intelligence-assisted diagnosis for rapid diagnosis of lung cancer.

Read the detailed description

To investigate the diagnostic efficacy of Femtosecond Laser Label-Free Imaging combined with artificial intelligence-assisted diagnosis for rapid diagnosis of lung cancer.

02

Conditions studied

  • Lung Cancer (Diagnosis)

Keywords

  • Lung Cancer
  • FLI
03

In context

Lung Neoplasms

5,422 studies on the registry are indexed under Lung Neoplasms; 1,346 are open to participants now.

This study's planned enrollment of 335 is above the median of 200 across 1,434 observational studies indexed under Lung Neoplasms.

Browse Lung Neoplasms studies →

Lead sponsor

Shanghai Zhongshan Hospital is the lead sponsor of 652 studies on the registry; 291 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Sampling method
Non-probability sample

Study population

Patients undergoing pulmonary resection, with specimens suitable for FLI diagnosis.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Pulmonary nodules detected by clinical imaging with an indication for surgical resection.
  2. Patient agrees to and is planned for pulmonary (partial) resection.
  3. Resected specimens are suitable for FLI imaging.
  4. Written obtained from the patient or legal representative.
  5. Patients undergoing pulmonary (partial) resection during this study.

Exclusion criteria

Exclusion Criteria:

  1. Insufficient sample.
  2. Specimen with crushing, contamination, or improper preservation, precluding valid imaging as judged by the investigator.
  3. Inability to obtain matched pathology results corresponding to FLI images.
  4. Inability to obtain final pathological diagnosis.
  5. Other conditions deemed by the investigator as unsuitable for study participation.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
335 participants (estimated)
Patient registry
No

Interventions

  • Diagnostic testFemtosecond Laser Label-Free Imaging Combined with Artificial Intelligence

    Femtosecond Laser Label-Free Imaging Combined with Artificial Intelligence. The diagnostic results will be blinded to both the physicians (including all clinicians involved in the patient's diagnostic and treatment process, such as surgeons and pathologists) and the patient, and the diagnostic results will NOT affect the original treatment plan.

06

What researchers measure

Primary outcomes

  1. The accuracy of FLI combined with AI-assisted diagnosis in differentiating benign from malignant lung surgical specimens.

    Time frame: through study completion, an average of 2 year

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Sep 2026; primary completion for Aug 2028, 23 months later.

Of 591 non-industry observational studies under Lung Neoplasms, half reached primary completion within 65 months of starting (the median), counting those still running; a quarter within 25 and three quarters within 162. This study's planned 23 months is below that.

Counting every sponsor, half of 681 studies reached it within 57 months; a quarter within 25 and three quarters within 135.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 24, 2026
First posted
Aug 31, 2026
StartEst.
Sep 1, 2026
Primary completionEst.
Aug 31, 2028
CompletionEst.
Aug 31, 2028
Last update
Aug 31, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 31, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07794449
Responsible party
Sponsor
First posted
Aug 31, 2026
Start date
Sep 1, 2026 (estimated)
Primary completion
Aug 31, 2028 (estimated)
Completion
Aug 31, 2028 (estimated)
Last update
Aug 31, 2026

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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