Label-free Femtosecond Laser Imaging Combined With the Fast Lung Artificial Intelligence Model for Rapid Intraoperative Diagnosis of Lung Surgical Specimens: A Multicentre, Prospective, Parallel-workflow, Non-inferiority Study.
Femtosecond Laser Imaging: Fresh 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: Fresh 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.
Study summary
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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
90 Years
Healthy volunteers
No
Inclusion Criteria:
1. Preoperative imaging suggests a pulmonary nodule, pulmonary space-occupying lesion, or suspected pulmonary tumor lesion.
2. The participant is scheduled to undergo pulmonary wedge resection, segmentectomy, lobectomy, or other pulmonary surgery.
3. Fresh lung tissue specimens can be obtained intraoperatively for femtosecond laser imaging.
4. Intraoperative frozen section diagnosis is planned to assess the nature of the tumor lesion.
5. Corresponding postoperative paraffin-embedded pathological diagnosis can be obtained.
6. The participant or the participant's legally authorized representative has signed the written informed consent form.
7. Patients had not received any antitumor treatment prior to enrollment or specimen collection, including chemotherapy, radiotherapy, targeted therapy, immunotherapy, or other systemic anticancer treatments.
Exclusion Criteria:
1. The intraoperative specimen is insufficient and cannot simultaneously meet the requirements for routine clinical pathological diagnosis and research-related testing.
2. The specimen shows severe carbonization, necrosis, compression, contamination, or improper preservation, and the investigator determines that effective imaging cannot be completed.
3. The femtosecond laser imaging specimen cannot be matched with the corresponding lesion assessed by final paraffin pathology.
4. Final paraffin-embedded pathological diagnosis cannot be obtained.
5. The participant withdraws informed consent.
6. Other conditions that, in the opinion of the investigator, make the participant unsuitable for this study.
Primary outcome measure(s)
Non-inferiority performance threshold — From intraoperative diagnosis to final paraffin pathology confirmation, up to 30 days after surgery. 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.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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