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.
調査の概要
詳細な説明
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.
研究の種類
観察的
入学 (推定)
294
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究連絡先
- 名前：Xinghua Cheng, Dr. PhD.
- 電話番号：17701681215
- メール：xinhuacheng@sjtu.edu.cn
研究場所
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-
Shanghai Municipality
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Shanghai、Shanghai Municipality、中国、200030
- 募集
- Shanghai Chest Hospital
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コンタクト：
- Yin Li, Dr.
- 電話番号：8618758824569
- メール：liy1398901568@163.com
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Shanghai、Shanghai Municipality、中国、200030
- まだ募集していません
- Dongfang Hospital
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コンタクト：
- Weigang Zhao, Dr.
- 電話番号：8618930170427
- メール：zhaowg@163.com
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Shanghai、Shanghai Municipality、中国、200030
- まだ募集していません
- Huadong Hospital
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コンタクト：
- Huibiao Zhang, Dr.
- 電話番号：8613916804033
- メール：huibiao_zhang@163.com
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Shanghai、Shanghai Municipality、中国、200030
- まだ募集していません
- Tongji Hospital
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コンタクト：
- wenli Wang, Dr.
- 電話番号：8613761295864
- メール：anderson840913@163.com
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Shanghai、Shanghai Municipality、中国、200030
- まだ募集していません
- Tongren Hospital
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コンタクト：
- ning Wang, Dr.
- 電話番号：8618017337120
- メール：WN3565@shtrhospital.com
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-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
いいえ
サンプリング方法
非確率サンプル
調査対象母集団
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.
説明
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.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
|
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.
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Non-inferiority performance threshold
時間枠：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.
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Workflow turnaround time
時間枠：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.
|
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Accuracy for invasive versus non-invasive/minimally invasive adenocarcinoma-spectrum lesions.
時間枠：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
時間枠：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
時間枠：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.
|
その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Diagnostic accuracy (ROC-AUC)
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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.
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
一般刊行物
- 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.
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2026年7月3日
一次修了 (推定)
2026年10月30日
研究の完了 (推定)
2026年11月30日
試験登録日
最初に提出
2026年6月22日
QC基準を満たした最初の提出物
2026年6月26日
最初の投稿 (実際)
2026年7月2日
学習記録の更新
投稿された最後の更新 (実際)
2026年9月4日
QC基準を満たした最後の更新が送信されました
2026年9月2日
最終確認日
2026年9月1日
詳しくは
本研究に関する用語
キーワード
追加の関連 MeSH 用語
その他の研究ID番号
- FastLung
- 2025SZ1002 (その他の助成金/資金番号：Foundation of Shanghai Key Laboratory of Thoracic Tumor Biotherapy)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
いいえ
IPD プランの説明
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.
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米国FDA規制医薬品の研究
いいえ
米国FDA規制機器製品の研究
いいえ
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