Pulmonary nodules, pulmonary space-occupying lesions, and suspected pulmonary malignancies, including but not limited to early-stage lung cancer, lung adenocarcinoma-spectrum lesions, lung squamous cell carcinoma, pulmonary metastatic malignancies, and inflammatory or other benign pulmonary lesions.
Conditions
Interventions
Gold Standard:Postoperative paraffin-embedded pathology will serve as the reference standard for all diagnostic accuracy analyses.
Index test:Intraoperative rapid diagnostic method for lung surgical specimens using label-free femtosecond laser imaging (FLI) combined with the Fast Lung artificial intelligence model.
Sponsors
Shanghai Chest Hospital
Eligibility
Sex/Gender
All
Age
14 Years to 90 Years
Inclusion criteria
Inclusion criteria: 1.Preoperative imaging indicates pulmonary nodules, pulmonary space-occupying lesions, or suspected pulmonary neoplastic lesions; 2.The patient is scheduled to undergo pulmonary wedge resection, segmentectomy, lobectomy, or other pulmonary surgery; 3.Fresh lung tissue samples can be obtained intraoperatively for FLI imaging; 4.Intraoperative frozen-section pathology is planned to assess the nature of the tumor; 5.Postoperative paraffin-embedded pathological diagnosis of the corresponding lesion can be obtained; 6.The patient or his/her legally authorized representative has signed the informed consent form;
Exclusion criteria
Exclusion criteria: 1.The intraoperative sample volume is insufficient to meet the requirements of both routine clinical pathological diagnosis and research testing; 2.The sample shows severe carbonization, necrosis, compression, contamination, or improper preservation, and is judged by the investigator to be unsuitable for valid imaging; 3.The FLI-imaged sample cannot be matched with the lesion diagnosed by final paraffin-embedded pathology; 4.The final paraffin-embedded pathological diagnosis cannot be obtained; 5.The patient withdraws informed consent; 6.Other circumstances in which the investigator considers the patient unsuitable for participation in this study;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall accuracy for benign–malignant diagnosis; | — |
Secondary
| Measure | Time frame |
|---|---|
| Specificity for benign lesions;Diagnostic turnaround time;Accuracy for adenocarcinoma invasive-status classification;Sensitivity for malignant lesions; | — |
Countries
China
Contacts
Public ContactXinghua Cheng
Shanghai Chest Hospital
Outcome results
None listed