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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.

3. července 2026 aktualizováno: 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.

Přehled studie

Postavení

Nábor

Podmínky

Intervence / Léčba

Detailní popis

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.

Typ studie

Pozorovací

Zápis (Odhadovaný)

294

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní kontakt

Studijní místa

  • Čína
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, Čína, 200030
        • Nábor
        • Shanghai Chest Hospital
        • Kontakt:
      • Shanghai, Shanghai Municipality, Čína, 200030
        • Zatím nenabíráme
        • Dongfang Hospital
        • Kontakt:
          • Weigang Zhao, Dr.
          • Telefonní číslo: 8618930170427
          • E-mail: zhaowg@163.com
      • Shanghai, Shanghai Municipality, Čína, 200030
        • Zatím nenabíráme
        • Huadong Hospital
        • Kontakt:
      • Shanghai, Shanghai Municipality, Čína, 200030
        • Zatím nenabíráme
        • Tongji Hospital
        • Kontakt:
      • Shanghai, Shanghai Municipality, Čína, 200030
        • Zatím nenabíráme
        • Tongren Hospital
        • Kontakt:

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

  • Dospělý
  • Starší dospělý

Přijímá zdravé dobrovolníky

Ne

Metoda odběru vzorků

Vzorek nepravděpodobnosti

Studijní populace

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.

Popis

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.

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.

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

Kohorty a intervence

Skupina / kohorta
Intervence / Léčba
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.
Diagnostický test: 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.
Diagnostický test: 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.

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Non-inferiority performance threshold
Časové okno: 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.

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Workflow turnaround time
Časové okno: 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.
Časové okno: 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
Časové okno: 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
Časové okno: 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.

Další výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Diagnostic accuracy (ROC-AUC)
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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.

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

Shanghai Chest Hospital

Spolupracovníci

Femtosecond Applications and Research (Guangzhou)

Publikace a užitečné odkazy

Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.

Obecné publikace

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Aktuální)

3. července 2026

Primární dokončení (Odhadovaný)

30. srpna 2026

Dokončení studie (Odhadovaný)

30. září 2026

Termíny zápisu do studia

První předloženo

22. června 2026

První předloženo, které splnilo kritéria kontroly kvality

26. června 2026

První zveřejněno (Aktuální)

2. července 2026

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

7. července 2026

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

3. července 2026

Naposledy ověřeno

1. července 2026

Více informací

Termíny související s touto studií

Klíčová slova

Další relevantní podmínky MeSH

Další identifikační čísla studie

  • FastLung
  • 2025SZ1002 (Jiné číslo grantu/financování: Foundation of Shanghai Key Laboratory of Thoracic Tumor Biotherapy)

Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

NE

Popis plánu IPD

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.

Informace o lécích a zařízeních, studijní dokumenty

Studuje lékový produkt regulovaný americkým FDA

Ne

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ne

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