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

NCT07794449 — Not yet recruiting, 335 participants, Shanghai Zhongshan Hospital

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Registry	NCT07794449
Status	Not yet recruiting
Study type	Observational
Enrollment	335 (Estimated)
Sponsor	Shanghai Zhongshan Hospital (Other)
Conditions	Lung Cancer (Diagnosis)
Interventions	Femtosecond Laser Label-Free Imaging Combined with Artificial Intelligence (Diagnostic test)
Dates	start 2026-09-01 (estimated), primary completion 2028-08-31 (estimated), completion 2028-08-31 (estimated), first posted 2026-08-31, last updated 2026-08-31

-Summary

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

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+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.

+Arms and interventions

Femtosecond Laser Label-Free Imaging Combined with Artificial Intelligence (Diagnostic test): 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.

+Outcome measures

Primary outcomes

The accuracy of FLI combined with AI-assisted diagnosis in differentiating benign from malignant lung surgical specimens. [through study completion, an average of 2 year]

+Eligibility

Sex: All

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:

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.