A Multicenter Prospective Study Evaluating the Diagnostic Performance of Femtosecond Laser Label-Free Imaging Combined With Artificial Intelligence for Predicting High-Risk Pathological Features in Lung Cancer

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorShanghai Zhongshan Hospital

About this trial

To investigate the diagnostic performance of Femtosecond Laser Label-Free Imaging combined with artificial intelligence for predicting high-risk pathological features in lung cancer

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Pulmonary nodules detected by clinical imaging with an indication for surgical resection.

Patient agrees to and is planned for pulmonary (partial) resection.

Resected specimens are suitable for FLI imaging.

Written informed consent obtained from the patient or legal representative.

Disqualifiers

Insufficient sample.

Specimen with crushing, contamination, or improper preservation, precluding valid imaging as judged by the investigator.

Inability to obtain matched pathology results corresponding to FLI images.

Inability to obtain final pathological diagnosis.

Trial population

Lung cancer patients undergoing pulmonary resection.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • 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.

Treatment groups

No treatment groups listed

Trial outcomes

Primary outcomes

1

The primary endpoint is the accuracy of the FLI combined with the AI model in predicting regional lymph node metastasis status in lung cancer, evaluated using postoperative pathology results as the reference standard.

Time frame
through study completion, an average of 2 year

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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