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.
2026年9月2日 更新者：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.
研究概览
详细说明
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.
研究类型
观察性的
注册 (估计的)
294
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Xinghua Cheng, Dr. PhD.
- 电话号码：17701681215
- 邮箱：xinhuacheng@sjtu.edu.cn
学习地点
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Shanghai Municipality
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Shanghai、Shanghai Municipality、中国、200030
- 招聘中
- Shanghai Chest Hospital
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接触：
- Yin Li, Dr.
- 电话号码：8618758824569
- 邮箱：liy1398901568@163.com
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Shanghai、Shanghai Municipality、中国、200030
- 尚未招聘
- Dongfang Hospital
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接触：
- Weigang Zhao, Dr.
- 电话号码：8618930170427
- 邮箱：zhaowg@163.com
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Shanghai、Shanghai Municipality、中国、200030
- 尚未招聘
- Huadong Hospital
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接触：
- Huibiao Zhang, Dr.
- 电话号码：8613916804033
- 邮箱：huibiao_zhang@163.com
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Shanghai、Shanghai Municipality、中国、200030
- 尚未招聘
- Tongji Hospital
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接触：
- wenli Wang, Dr.
- 电话号码：8613761295864
- 邮箱：anderson840913@163.com
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Shanghai、Shanghai Municipality、中国、200030
- 尚未招聘
- Tongren Hospital
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接触：
- ning Wang, Dr.
- 电话号码：8618017337120
- 邮箱：WN3565@shtrhospital.com
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
不
取样方法
非概率样本
研究人群
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.
描述
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.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
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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.
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Non-inferiority performance threshold
大体时间：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.
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From intraoperative diagnosis to final paraffin pathology confirmation, up to 30 days after surgery.
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Workflow turnaround time
大体时间：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.
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From intraoperative diagnosis to final paraffin pathology confirmation, up to 30 days after surgery.
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Accuracy for invasive versus non-invasive/minimally invasive adenocarcinoma-spectrum lesions.
大体时间：From intraoperative diagnosis to final paraffin pathology confirmation, up to 30 days after surgery.
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To evaluate the accuracy of Fast Lung for invasive versus non-invasive/minimally invasive adenocarcinoma-spectrum lesions.
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From intraoperative diagnosis to final paraffin pathology confirmation, up to 30 days after surgery.
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Sensitivity
大体时间：From intraoperative diagnosis to final paraffin pathology confirmation, up to 30 days after surgery.
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To estimate the sensitivity of Fast Lung for malignant lesions using FFPE histopathology as the reference standard.
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From intraoperative diagnosis to final paraffin pathology confirmation, up to 30 days after surgery.
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Specificity
大体时间：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.
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From intraoperative diagnosis to final paraffin pathology confirmation, up to 30 days after surgery.
|
其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Diagnostic accuracy (ROC-AUC)
大体时间：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.
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From intraoperative diagnosis to final paraffin pathology confirmation, up to 30 days after surgery.
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Performance of histological subtype diagnostic
大体时间：From intraoperative diagnosis to final paraffin pathology confirmation, up to 30 days after surgery.
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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.
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From intraoperative diagnosis to final paraffin pathology confirmation, up to 30 days after surgery.
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Performance in biopsy or small-tissue specimens
大体时间：From intraoperative diagnosis to final paraffin pathology confirmation, up to 30 days after surgery.
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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.
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Diagnostic Failure Rate
大体时间：From intraoperative diagnosis to final paraffin pathology confirmation, up to 30 days after surgery.
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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.
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False Positive Rate
大体时间：From intraoperative diagnosis to final paraffin pathology confirmation, up to 30 days after surgery.
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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 (%).
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From intraoperative diagnosis to final paraffin pathology confirmation, up to 30 days after surgery.
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False Negative Rate
大体时间：From intraoperative diagnosis to final paraffin pathology confirmation, up to 30 days after surgery.
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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 (%).
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From intraoperative diagnosis to final paraffin pathology confirmation, up to 30 days after surgery.
|
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Heatmap-pathology concordance
大体时间：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.
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From intraoperative diagnosis to final paraffin pathology confirmation, up to 30 days after surgery.
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- 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.
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2026年7月3日
初级完成 (估计的)
2026年10月30日
研究完成 (估计的)
2026年11月30日
研究注册日期
首次提交
2026年6月22日
首先提交符合 QC 标准的
2026年6月26日
首次发布 (实际的)
2026年7月2日
研究记录更新
最后更新发布 (实际的)
2026年9月4日
上次提交的符合 QC 标准的更新
2026年9月2日
最后验证
2026年9月1日
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- FastLung
- 2025SZ1002 (其他赠款/资助编号：Foundation of Shanghai Key Laboratory of Thoracic Tumor Biotherapy)
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
不
IPD 计划说明
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.
药物和器械信息、研究文件
研究美国 FDA 监管的药品
不
研究美国 FDA 监管的设备产品
不
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