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.

NCT07681245 | Recruiting DMC

• 2 other identifiers: FastLung2025SZ1002
• Study Type: observational
• Target: 294
• Locations: 1 country
• Sites: 5

Brief 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.

Conditions

Lung Cancer

Keywords

lung cancer; artificial intelligence; Intraoperative diagnosis

Outcome Measures

Primary Outcomes (1)

• 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.

  From intraoperative diagnosis to final paraffin pathology confirmation, up to 30 days after surgery.

Secondary Outcomes (4)

• Workflow turnaround time

  From intraoperative diagnosis to final paraffin pathology confirmation, up to 30 days after surgery.

• Accuracy for invasive versus non-invasive/minimally invasive adenocarcinoma-spectrum lesions.

  From intraoperative diagnosis to final paraffin pathology confirmation, up to 30 days after surgery.

• Sensitivity

  From intraoperative diagnosis to final paraffin pathology confirmation, up to 30 days after surgery.

• Specificity

  From intraoperative diagnosis to final paraffin pathology confirmation, up to 30 days after surgery.

Other Outcomes (7)

• Diagnostic accuracy (ROC-AUC)

  From intraoperative diagnosis to final paraffin pathology confirmation, up to 30 days after surgery.

• Performance of histological subtype diagnostic

  From intraoperative diagnosis to final paraffin pathology confirmation, up to 30 days after surgery.

• Performance in biopsy or small-tissue specimens

  From intraoperative diagnosis to final paraffin pathology confirmation, up to 30 days after surgery.

Study Arms (1)

Patients undergoing intraoperative pulmonary nodule diagnosis

Patients with pulmonary nodules who are scheduled for surgical resection and require intraoperative pathological assessment. All participants will undergo femtosecond laser imaging and standard frozen section diagnosis in parallel, and both results will be compared with final paraffin pathology as the reference standard.

Diagnostic Test: Femtosecond Laser Imaging; Diagnostic Test: Frozen Section Diagnosis

Interventions

Femtosecond Laser Imaging DIAGNOSTIC_TEST

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.

Patients undergoing intraoperative pulmonary nodule diagnosis

Frozen Section Diagnosis DIAGNOSTIC_TEST

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.

Patients undergoing intraoperative pulmonary nodule diagnosis

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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.
• Corresponding postoperative paraffin-embedded pathological diagnosis can be obtained.
• The participant or the participant's legally authorized representative has signed the written informed consent form.

You may not qualify if:

• 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 participant withdraws informed consent.
• Other conditions that, in the opinion of the investigator, make the participant unsuitable for this study.

Sponsors & Collaborators

• Shanghai Chest Hospital: lead
• Femtosecond Applications and Research (Guangzhou): collaborator

Study Sites (5)

Dongfang Hospital

Shanghai, Shanghai Municipality, 200030, China

NOT YET RECRUITING

Huadong Hospital

Shanghai, Shanghai Municipality, 200030, China

NOT YET RECRUITING

Shanghai Chest Hospital

Shanghai, Shanghai Municipality, 200030, China

RECRUITING

Tongji Hospital

Shanghai, Shanghai Municipality, 200030, China

NOT YET RECRUITING

Tongren Hospital

Shanghai, Shanghai Municipality, 200030, China

NOT YET RECRUITING

Related Publications (3)

• Xu X, Chung JH, Jheon S, Sung SW, Lee CT, Lee JH, Choe G. The accuracy of frozen section diagnosis of pulmonary nodules: evaluation of inflation method during intraoperative pathology consultation with cryosection. J Thorac Oncol. 2010 Jan;5(1):39-44. doi: 10.1097/JTO.0b013e3181c09f9c.

  PMID: 19934776 BACKGROUND

• Hollon TC, Pandian B, Adapa AR, Urias E, Save AV, Khalsa SSS, Eichberg DG, D'Amico RS, Farooq ZU, Lewis S, Petridis PD, Marie T, Shah AH, Garton HJL, Maher CO, Heth JA, McKean EL, Sullivan SE, Hervey-Jumper SL, Patil PG, Thompson BG, Sagher O, McKhann GM 2nd, Komotar RJ, Ivan ME, Snuderl M, Otten ML, Johnson TD, Sisti MB, Bruce JN, Muraszko KM, Trautman J, Freudiger CW, Canoll P, Lee H, Camelo-Piragua S, Orringer DA. Near real-time intraoperative brain tumor diagnosis using stimulated Raman histology and deep neural networks. Nat Med. 2020 Jan;26(1):52-58. doi: 10.1038/s41591-019-0715-9. Epub 2020 Jan 6.

  PMID: 31907460 BACKGROUND

• Lan C, Peng Y, Bai M, Zuo H, Li Y, Wu H, Zhang T, Zhu X, He J, Guo D, Chen X, Zhao H, Gao H. Fast multimodal imaging combined with machine learning identifying taurine as a potential marker for breast cancer margin assessment. NPJ Digit Med. 2025 Dec 17;9(1):32. doi: 10.1038/s41746-025-02202-z.

  PMID: 41402452 BACKGROUND

MeSH Terms

Conditions

Lung Neoplasms

Interventions

Frozen Sections

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Cryoultramicrotomy; Microtomy; Histocytological Preparation Techniques; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Histological Techniques; Investigative Techniques

Central Study Contacts

Xinghua Cheng, Dr. PhD.

CONTACT

17701681215; xinhuacheng@sjtu.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 30 Days
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: June 22, 2026
• First Posted: July 2, 2026
• Study Start: July 3, 2026
• Primary Completion (Estimated): August 30, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: July 7, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (5)