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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.

2 september 2026 bijgewerkt door: Xinghua Cheng, Shanghai Chest Hospital
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.

Studie Overzicht

Toestand

Werving

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

This is a prospective, multicenter, paired diagnostic accuracy study designed to evaluate the non-inferiority of femtosecond laser imaging compared with standard frozen section diagnosis for intraoperative assessment of pulmonary nodules or suspected pulmonary tumor lesions.

Eligible patients with pulmonary nodules, pulmonary space-occupying lesions, or suspected pulmonary tumor lesions who are scheduled to undergo surgical resection and require intraoperative pathological assessment will be prospectively enrolled from participating centers. After surgical excision of the tumor specimen, the fresh specimen will be bisected through the central plane. One half of the specimen will be submitted for routine frozen section diagnosis, while the mirrored counterpart will be used for femtosecond laser imaging. This paired design is intended to allow spatially corresponding comparison between the two diagnostic methods while preserving routine clinical workflow.

Frozen section diagnosis will be performed according to standard intraoperative pathological procedures and will continue to guide intraoperative clinical decision-making. Femtosecond laser imaging will be performed on fresh tissue specimens for research purposes. The imaging results will be recorded for diagnostic performance evaluation but will not be used to guide intraoperative surgical decisions.

The diagnostic results of femtosecond laser imaging and frozen section diagnosis will both be compared with the final paraffin-embedded pathological diagnosis, which will serve as the reference standard. The primary objective is to determine whether the diagnostic accuracy of femtosecond laser imaging is non-inferior to that of frozen section diagnosis. Secondary objectives may include comparisons of sensitivity, specificity, positive predictive value, negative predictive value, diagnostic concordance, and intraoperative assessment time between the two methods.

Studietype

Observationeel

Inschrijving (Geschat)

294

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Locaties

  • China
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China, 200030
        • Werving
        • Shanghai Chest Hospital
        • Contact:
      • Shanghai, Shanghai Municipality, China, 200030
        • Nog niet aan het werven
        • Dongfang Hospital
        • Contact:
          • Weigang Zhao, Dr.
          • Telefoonnummer: 8618930170427
          • E-mail: zhaowg@163.com
      • Shanghai, Shanghai Municipality, China, 200030
        • Nog niet aan het werven
        • Huadong Hospital
        • Contact:
      • Shanghai, Shanghai Municipality, China, 200030
        • Nog niet aan het werven
        • Tongji Hospital
        • Contact:
      • Shanghai, Shanghai Municipality, China, 200030
        • Nog niet aan het werven
        • Tongren Hospital
        • Contact:

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Bemonsteringsmethode

Niet-waarschijnlijkheidssteekproef

Studie Bevolking

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.

Beschrijving

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

Cohorten en interventies

Groep / Cohort
Interventie / Behandeling
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.
Diagnostische toets: 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.
Diagnostische toets: 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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Non-inferiority performance threshold
Tijdsspanne: 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.
From intraoperative diagnosis to final paraffin pathology confirmation, up to 30 days after surgery.

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Workflow turnaround time
Tijdsspanne: From intraoperative diagnosis to final paraffin pathology confirmation, up to 30 days after surgery.
To compare workflow turnaround time for FLI + Fast Lung and routine frozen-section pathology.
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.
Tijdsspanne: From intraoperative diagnosis to final paraffin pathology confirmation, up to 30 days after surgery.
To evaluate the accuracy of Fast Lung 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
Tijdsspanne: From intraoperative diagnosis to final paraffin pathology confirmation, up to 30 days after surgery.
To estimate the sensitivity of Fast Lung for malignant lesions using FFPE histopathology as the reference standard.
From intraoperative diagnosis to final paraffin pathology confirmation, up to 30 days after surgery.
Specificity
Tijdsspanne: From intraoperative diagnosis to final paraffin pathology confirmation, up to 30 days after surgery.
To estimate the specificity of Fast Lung for benign lesions using FFPE histopathology as the reference standard.
From intraoperative diagnosis to final paraffin pathology confirmation, up to 30 days after surgery.

Andere uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Diagnostic accuracy (ROC-AUC)
Tijdsspanne: From intraoperative diagnosis to final paraffin pathology confirmation, up to 30 days after surgery.
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.
From intraoperative diagnosis to final paraffin pathology confirmation, up to 30 days after surgery.
Performance of histological subtype diagnostic
Tijdsspanne: From intraoperative diagnosis to final paraffin pathology confirmation, up to 30 days after surgery.
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.
From intraoperative diagnosis to final paraffin pathology confirmation, up to 30 days after surgery.
Performance in biopsy or small-tissue specimens
Tijdsspanne: From intraoperative diagnosis to final paraffin pathology confirmation, up to 30 days after surgery.
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.
From intraoperative diagnosis to final paraffin pathology confirmation, up to 30 days after surgery.
Diagnostic Failure Rate
Tijdsspanne: From intraoperative diagnosis to final paraffin pathology confirmation, up to 30 days after surgery.
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.
From intraoperative diagnosis to final paraffin pathology confirmation, up to 30 days after surgery.
False Positive Rate
Tijdsspanne: From intraoperative diagnosis to final paraffin pathology confirmation, up to 30 days after surgery.
False positive rate will be calculated as the proportion of cases incorrectly classified as positive by the FLI-FastLung model when compared with final paraffin pathology as the reference standard. The result will be derived from a confusion matrix and expressed as a percentage (%).
From intraoperative diagnosis to final paraffin pathology confirmation, up to 30 days after surgery.
False Negative Rate
Tijdsspanne: From intraoperative diagnosis to final paraffin pathology confirmation, up to 30 days after surgery.
False negative rate will be calculated as the proportion of cases incorrectly classified as negative by the FLI-FastLung model when compared with final paraffin pathology as the reference standard. The result will be derived from a confusion matrix and expressed as a percentage (%).
From intraoperative diagnosis to final paraffin pathology confirmation, up to 30 days after surgery.
Heatmap-pathology concordance
Tijdsspanne: From intraoperative diagnosis to final paraffin pathology confirmation, up to 30 days after surgery.
Concordance between FastLung-generated heatmaps and corresponding pathological tumor regions will be evaluated using spatial overlap metrics. The primary measurement will be the Dice similarity coefficient (DSC) between model-generated heatmap regions and manually annotated pathological tumor areas. Results will be expressed as a continuous score ranging from 0 to 1.
From intraoperative diagnosis to final paraffin pathology confirmation, up to 30 days after surgery.

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Shanghai Chest Hospital

Medewerkers

Femtosecond Applications and Research (Guangzhou)

Publicaties en nuttige links

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Algemene publicaties

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

3 juli 2026

Primaire voltooiing (Geschat)

30 oktober 2026

Studie voltooiing (Geschat)

30 november 2026

Studieregistratiedata

Eerst ingediend

22 juni 2026

Eerst ingediend dat voldeed aan de QC-criteria

26 juni 2026

Eerst geplaatst (Werkelijk)

2 juli 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

4 september 2026

Laatste update ingediend die voldeed aan QC-criteria

2 september 2026

Laatst geverifieerd

1 september 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • FastLung
  • 2025SZ1002 (Ander subsidie-/financieringsnummer: Foundation of Shanghai Key Laboratory of Thoracic Tumor Biotherapy)

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Beschrijving IPD-plan

Individual participant data will not be publicly shared due to patient privacy considerations and institutional data-sharing restrictions. De-identified aggregate results may be made available in publications or upon reasonable request, in accordance with applicable regulations and institutional policies.

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

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