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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

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.

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 informed consent 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.
04

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.

05

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

06

Study locations

No study locations are listed for this record.

07

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT07794449
Lead sponsor
Shanghai Zhongshan Hospital
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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