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 septembre 2026 mis à jour par: 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.
Aperçu de l'étude
Statut
Recrutement
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Observationnel
Inscription (Estimé)
294
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Coordonnées de l'étude
- Nom: Xinghua Cheng, Dr. PhD.
- Numéro de téléphone: 17701681215
- E-mail: xinhuacheng@sjtu.edu.cn
Lieux d'étude
-
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Shanghai Municipality
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Shanghai, Shanghai Municipality, Chine, 200030
- Recrutement
- Shanghai Chest Hospital
-
Contact:
- Yin Li, Dr.
- Numéro de téléphone: 8618758824569
- E-mail: liy1398901568@163.com
-
Shanghai, Shanghai Municipality, Chine, 200030
- Pas encore de recrutement
- Dongfang Hospital
-
Contact:
- Weigang Zhao, Dr.
- Numéro de téléphone: 8618930170427
- E-mail: zhaowg@163.com
-
Shanghai, Shanghai Municipality, Chine, 200030
- Pas encore de recrutement
- Huadong Hospital
-
Contact:
- Huibiao Zhang, Dr.
- Numéro de téléphone: 8613916804033
- E-mail: huibiao_zhang@163.com
-
Shanghai, Shanghai Municipality, Chine, 200030
- Pas encore de recrutement
- Tongji Hospital
-
Contact:
- wenli Wang, Dr.
- Numéro de téléphone: 8613761295864
- E-mail: anderson840913@163.com
-
Shanghai, Shanghai Municipality, Chine, 200030
- Pas encore de recrutement
- Tongren Hospital
-
Contact:
- ning Wang, Dr.
- Numéro de téléphone: 8618017337120
- E-mail: WN3565@shtrhospital.com
-
-
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Non
Méthode d'échantillonnage
Échantillon non probabiliste
Population étudiée
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.
La description
Inclusion Criteria:
- 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.
- 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:
- 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.
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / Cohorte |
Intervention / Traitement |
|---|---|
|
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.
|
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.
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.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Non-inferiority performance threshold
Délai: 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.
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Workflow turnaround time
Délai: 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.
Délai: 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
Délai: 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
Délai: 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.
|
Autres mesures de résultats
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Diagnostic accuracy (ROC-AUC)
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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.
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Collaborateurs
Publications et liens utiles
La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.
Publications générales
- 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.
- 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.
- 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.
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
3 juillet 2026
Achèvement primaire (Estimé)
30 octobre 2026
Achèvement de l'étude (Estimé)
30 novembre 2026
Dates d'inscription aux études
Première soumission
22 juin 2026
Première soumission répondant aux critères de contrôle qualité
26 juin 2026
Première publication (Réel)
2 juillet 2026
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
4 septembre 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
2 septembre 2026
Dernière vérification
1 septembre 2026
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
- Tumeurs par site
- Tumeurs
- Maladies des voies respiratoires
- Maladies pulmonaires
- Tumeurs des voies respiratoires
- Tumeurs thoraciques
- Tumeurs pulmonaires
- Techniques d'investigation
- Techniques de laboratoire clinique
- Techniques et procédures de diagnostic
- Diagnostic
- Techniques cytologiques
- Techniques histologiques
- Techniques de préparation histocytologique
- Cryoultramicrotomie
- Microtomie
- Coupes Congelées
Autres numéros d'identification d'étude
- FastLung
- 2025SZ1002 (Autre subvention/numéro de financement: Foundation of Shanghai Key Laboratory of Thoracic Tumor Biotherapy)
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
NON
Description du régime 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.
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .