This study aims to evaluate whether femtosecond laser imaging combined with FastLung AI model can provide intraoperative diagnostic performance that is non-inferior to standard frozen section diagnosis for pulmonary nodules or suspected pulmonary tumor lesions. Patients scheduled for lung surgery and requiring intraoperative pathological assessment will be prospectively enrolled. After tumor excision, the fresh tumor specimen will be bisected through the central plane. One half will be used for standard frozen section diagnosis, and the mirrored counterpart will be used for femtosecond laser imaging. Both diagnostic results will be compared with the final paraffin-embedded pathological diagnosis as the reference standard. The results of femtosecond laser imaging will not guide intraoperative clinical decision-making.
Preoperative imaging suggests a pulmonary nodule, pulmonary space-occupying lesion, or suspected pulmonary tumor lesion.
The participant is scheduled to undergo pulmonary wedge resection, segmentectomy, lobectomy, or other pulmonary surgery.
Fresh lung tissue specimens can be obtained intraoperatively for femtosecond laser imaging.
Intraoperative frozen section diagnosis is planned to assess the nature of the tumor lesion.
The intraoperative specimen is insufficient and cannot simultaneously meet the requirements for routine clinical pathological diagnosis and research-related testing.
The specimen shows severe carbonization, necrosis, compression, contamination, or improper preservation, and the investigator determines that effective imaging cannot be completed.
The femtosecond laser imaging specimen cannot be matched with the corresponding lesion assessed by final paraffin pathology.
Final paraffin-embedded pathological diagnosis cannot be obtained.
The study population will consist of patients with pulmonary nodules, pulmonary space-occupying lesions, or suspected pulmonary tumor lesions who are scheduled to undergo surgical resection at participating centers. Eligible patients will require intraoperative pathological assessment, and fresh lung tissue specimens must be available for both femtosecond laser imaging and standard frozen section diagnosis. All participants will be prospectively enrolled according to the predefined inclusion and exclusion criteria, and the diagnostic results will be compared with the final paraffin-embedded pathological diagnosis as the reference standard.
Cohort
Prospective
Femtosecond Laser Imaging
Diagnostic testFresh surgical specimens will be examined intraoperatively using femtosecond laser imaging. The imaging results will be recorded for diagnostic performance evaluation and compared with final paraffin pathology. The results will not guide intraoperative clinical decision-making.
Frozen Section Diagnosis
Diagnostic testFresh tumor specimens will be evaluated intraoperatively by standard frozen section pathology. After the tumor is bisected through the central plane, one half of the specimen will be submitted for frozen section diagnosis, while the mirrored counterpart will be used for femtosecond laser imaging. Frozen section diagnosis will be used for routine intraoperative clinical decision-making and will also be compared with final paraffin pathology.
Non-inferiority performance threshold
To determine whether FLI combined with Fast Lung achieves the prespecified non-inferiority performance threshold for benign-malignant diagnosis of the patient-level primary target lesion, using final FFPE histopathology as the reference standard.
Workflow turnaround time
To compare workflow turnaround time for FLI + Fast Lung and routine frozen-section pathology.
Accuracy for invasive versus non-invasive/minimally invasive adenocarcinoma-spectrum lesions.
To evaluate the accuracy of Fast Lung for invasive versus non-invasive/minimally invasive adenocarcinoma-spectrum lesions.
Sensitivity
To estimate the sensitivity of Fast Lung for malignant lesions using FFPE histopathology as the reference standard.
Specificity
To estimate the specificity of Fast Lung for benign lesions using FFPE histopathology as the reference standard.
Diagnostic accuracy (ROC-AUC)
The area under the receiver operating characteristic curve (ROC-AUC) will be used to assess the overall diagnostic accuracy of FLI-FastLung model in etermination of the benign or malignant of surgical specimens compared with final paraffin pathology as the reference standard.
Performance of histological subtype diagnostic
The performance of the FLI-FastLung model in distinguishing LUAD from LUSC will be evaluated using final paraffin pathology as the reference standard. Diagnostic performance will be quantified by area under the ROC curve (ROC-AUC), overall accuracy, sensitivity, and specificity.
Performance in biopsy or small-tissue specimens
The performance of the FLI-FastLung model in biopsy or small tissue specimens will be assessed using final paraffin pathology as the reference standard. Diagnostic performance will be quantified by area under the ROC curve (ROC-AUC), overall accuracy, sensitivity, and specificity.
Diagnostic Failure Rate
Diagnostic failure rate refers to the proportion of cases in which the FLI-FastLung system is unable to generate a valid histological classification result. A diagnostic failure is defined as the absence of a final output due to inadequate image quality, insufficient tissue input, or system processing failure.
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Shanghai Chest Hospital
Lead sponsor
Femtosecond Applications and Research (Guangzhou)
Collaborator
