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 uppdaterad av: 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.
Studieöversikt
Status
Rekrytering
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Observationell
Inskrivning (Beräknad)
294
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studiekontakt
- Namn: Xinghua Cheng, Dr. PhD.
- Telefonnummer: 17701681215
- E-post: xinhuacheng@sjtu.edu.cn
Studieorter
-
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Shanghai Municipality
-
Shanghai, Shanghai Municipality, Kina, 200030
- Rekrytering
- Shanghai Chest Hospital
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Kontakt:
- Yin Li, Dr.
- Telefonnummer: 8618758824569
- E-post: liy1398901568@163.com
-
Shanghai, Shanghai Municipality, Kina, 200030
- Har inte rekryterat ännu
- Dongfang Hospital
-
Kontakt:
- Weigang Zhao, Dr.
- Telefonnummer: 8618930170427
- E-post: zhaowg@163.com
-
Shanghai, Shanghai Municipality, Kina, 200030
- Har inte rekryterat ännu
- Huadong Hospital
-
Kontakt:
- Huibiao Zhang, Dr.
- Telefonnummer: 8613916804033
- E-post: huibiao_zhang@163.com
-
Shanghai, Shanghai Municipality, Kina, 200030
- Har inte rekryterat ännu
- Tongji Hospital
-
Kontakt:
- wenli Wang, Dr.
- Telefonnummer: 8613761295864
- E-post: anderson840913@163.com
-
Shanghai, Shanghai Municipality, Kina, 200030
- Har inte rekryterat ännu
- Tongren Hospital
-
Kontakt:
- ning Wang, Dr.
- Telefonnummer: 8618017337120
- E-post: WN3565@shtrhospital.com
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Nej
Testmetod
Icke-sannolikhetsprov
Studera befolkning
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.
Beskrivning
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.
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
Kohorter och interventioner
Grupp / Kohort |
Intervention / Behandling |
|---|---|
|
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.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Non-inferiority performance threshold
Tidsram: 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.
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Workflow turnaround time
Tidsram: 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.
Tidsram: 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
Tidsram: 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
Tidsram: 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.
|
Andra resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Diagnostic accuracy (ROC-AUC)
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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.
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Samarbetspartners
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Allmänna publikationer
- 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.
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
3 juli 2026
Primärt slutförande (Beräknad)
30 oktober 2026
Avslutad studie (Beräknad)
30 november 2026
Studieregistreringsdatum
Först inskickad
22 juni 2026
Först inskickad som uppfyllde QC-kriterierna
26 juni 2026
Första postat (Faktisk)
2 juli 2026
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
4 september 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
2 september 2026
Senast verifierad
1 september 2026
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
- Neoplasmer efter plats
- Neoplasmer
- Luftvägssjukdomar
- Lungsjukdomar
- Neoplasmer i andningsvägarna
- Thoracic neoplasmer
- Lungneoplasmer
- Undersökningstekniker
- Kliniska laboratorietekniker
- Diagnostiska tekniker och procedurer
- Diagnos
- Cytologiska tekniker
- Histologiska tekniker
- Histocytologiska beredningstekniker
- Kryoultramikrotomi
- Mikrotomi
- Frysta snitt
Andra studie-ID-nummer
- FastLung
- 2025SZ1002 (Annat bidrag/finansieringsnummer: Foundation of Shanghai Key Laboratory of Thoracic Tumor Biotherapy)
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
NEJ
IPD-planbeskrivning
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.
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Nej
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