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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.

keskiviikko 2. syyskuuta 2026 päivittänyt: 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.

Tutkimuksen yleiskatsaus

Tila

Rekrytointi

Ehdot

Interventio / Hoito

Yksityiskohtainen kuvaus

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.

Opintotyyppi

Havainnollistava

Ilmoittautuminen (Arvioitu)

294

Yhteystiedot ja paikat

Tässä osiossa on tutkimuksen suorittajien yhteystiedot ja tiedot siitä, missä tämä tutkimus suoritetaan.

Opiskeluyhteys

Opiskelupaikat

  • Kiina
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, Kiina, 200030
        • Rekrytointi
        • Shanghai Chest Hospital
        • Ottaa yhteyttä:
      • Shanghai, Shanghai Municipality, Kiina, 200030
        • Ei vielä rekrytointia
        • Dongfang Hospital
        • Ottaa yhteyttä:
          • Weigang Zhao, Dr.
          • Puhelinnumero: 8618930170427
          • Sähköposti: zhaowg@163.com
      • Shanghai, Shanghai Municipality, Kiina, 200030
        • Ei vielä rekrytointia
        • Huadong Hospital
        • Ottaa yhteyttä:
      • Shanghai, Shanghai Municipality, Kiina, 200030
        • Ei vielä rekrytointia
        • Tongji Hospital
        • Ottaa yhteyttä:
      • Shanghai, Shanghai Municipality, Kiina, 200030
        • Ei vielä rekrytointia
        • Tongren Hospital
        • Ottaa yhteyttä:

Osallistumiskriteerit

Tutkijat etsivät ihmisiä, jotka sopivat tiettyyn kuvaukseen, jota kutsutaan kelpoisuuskriteereiksi. Joitakin esimerkkejä näistä kriteereistä ovat henkilön yleinen terveydentila tai aiemmat hoidot.

Kelpoisuusvaatimukset

Opintokelpoiset iät

  • Aikuinen
  • Vanhempi Aikuinen

Hyväksyy terveitä vapaaehtoisia

Ei

Näytteenottomenetelmä

Ei-todennäköisyysnäyte

Tutkimusväestö

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.

Kuvaus

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.

Opintosuunnitelma

Tässä osiossa on tietoja tutkimussuunnitelmasta, mukaan lukien kuinka tutkimus on suunniteltu ja mitä tutkimuksella mitataan.

Miten tutkimus on suunniteltu?

Suunnittelun yksityiskohdat

Kohortit ja interventiot

Ryhmä/Kohortti
Interventio / Hoito
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.
Diagnostinen testi: 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.
Diagnostinen testi: 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.

Mitä tutkimuksessa mitataan?

Ensisijaiset tulostoimenpiteet

Tulosmittaus
Toimenpiteen kuvaus
Aikaikkuna
Non-inferiority performance threshold
Aikaikkuna: 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.

Toissijaiset tulostoimenpiteet

Tulosmittaus
Toimenpiteen kuvaus
Aikaikkuna
Workflow turnaround time
Aikaikkuna: 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.
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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.

Muut tulostoimenpiteet

Tulosmittaus
Toimenpiteen kuvaus
Aikaikkuna
Diagnostic accuracy (ROC-AUC)
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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.

Yhteistyökumppanit ja tutkijat

Täältä löydät tähän tutkimukseen osallistuvat ihmiset ja organisaatiot.

Sponsori

Shanghai Chest Hospital

Yhteistyökumppanit

Femtosecond Applications and Research (Guangzhou)

Julkaisuja ja hyödyllisiä linkkejä

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Opintojen ennätyspäivät

Nämä päivämäärät seuraavat ClinicalTrials.gov-sivustolle lähetettyjen tutkimustietueiden ja yhteenvetojen edistymistä. National Library of Medicine (NLM) tarkistaa tutkimustiedot ja raportoidut tulokset varmistaakseen, että ne täyttävät tietyt laadunvalvontastandardit, ennen kuin ne julkaistaan ​​julkisella verkkosivustolla.

Opi tärkeimmät päivämäärät

Opiskelun aloitus (Todellinen)

Perjantai 3. heinäkuuta 2026

Ensisijainen valmistuminen (Arvioitu)

Perjantai 30. lokakuuta 2026

Opintojen valmistuminen (Arvioitu)

Maanantai 30. marraskuuta 2026

Opintoihin ilmoittautumispäivät

Ensimmäinen lähetetty

Maanantai 22. kesäkuuta 2026

Ensimmäinen toimitettu, joka täytti QC-kriteerit

Perjantai 26. kesäkuuta 2026

Ensimmäinen Lähetetty (Todellinen)

Torstai 2. heinäkuuta 2026

Tutkimustietojen päivitykset

Viimeisin päivitys julkaistu (Todellinen)

Perjantai 4. syyskuuta 2026

Viimeisin lähetetty päivitys, joka täytti QC-kriteerit

Keskiviikko 2. syyskuuta 2026

Viimeksi vahvistettu

Tiistai 1. syyskuuta 2026

Lisää tietoa

Tähän tutkimukseen liittyvät termit

Avainsanat

Muita asiaankuuluvia MeSH-ehtoja

Muut tutkimustunnusnumerot

  • FastLung
  • 2025SZ1002 (Muu apuraha/rahoitusnumero: Foundation of Shanghai Key Laboratory of Thoracic Tumor Biotherapy)

Yksittäisten osallistujien tietojen suunnitelma (IPD)

Aiotko jakaa yksittäisten osallistujien tietoja (IPD)?

EI

IPD-suunnitelman kuvaus

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.

Lääke- ja laitetiedot, tutkimusasiakirjat

Tutkii yhdysvaltalaista FDA sääntelemää lääkevalmistetta

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Tutkii yhdysvaltalaista FDA sääntelemää laitetuotetta

Ei

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