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 сентября 2026 г. обновлено: 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.
Обзор исследования
Статус
Рекрутинг
Условия
Подробное описание
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.
Тип исследования
Наблюдательный
Регистрация (Оцененный)
294
Контакты и местонахождение
В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.
Контакты исследования
- Имя: Xinghua Cheng, Dr. PhD.
- Номер телефона: 17701681215
- Электронная почта: xinhuacheng@sjtu.edu.cn
Места учебы
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Shanghai Municipality
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Shanghai, Shanghai Municipality, Китай, 200030
- Рекрутинг
- Shanghai Chest Hospital
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Контакт:
- Yin Li, Dr.
- Номер телефона: 8618758824569
- Электронная почта: liy1398901568@163.com
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Shanghai, Shanghai Municipality, Китай, 200030
- Еще не набирают
- Dongfang Hospital
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Контакт:
- Weigang Zhao, Dr.
- Номер телефона: 8618930170427
- Электронная почта: zhaowg@163.com
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Shanghai, Shanghai Municipality, Китай, 200030
- Еще не набирают
- Huadong Hospital
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Контакт:
- Huibiao Zhang, Dr.
- Номер телефона: 8613916804033
- Электронная почта: huibiao_zhang@163.com
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Shanghai, Shanghai Municipality, Китай, 200030
- Еще не набирают
- Tongji Hospital
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Контакт:
- wenli Wang, Dr.
- Номер телефона: 8613761295864
- Электронная почта: anderson840913@163.com
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Shanghai, Shanghai Municipality, Китай, 200030
- Еще не набирают
- Tongren Hospital
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Контакт:
- ning Wang, Dr.
- Номер телефона: 8618017337120
- Электронная почта: WN3565@shtrhospital.com
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Критерии участия
Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.
Критерии приемлемости
Возраст, подходящий для обучения
- Взрослый
- Пожилой взрослый
Принимает здоровых добровольцев
Нет
Метод выборки
Невероятностная выборка
Исследуемая популяция
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.
Описание
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.
Учебный план
В этом разделе представлена подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.
Как устроено исследование?
Детали дизайна
Когорты и вмешательства
Группа / когорта |
Вмешательство/лечение |
|---|---|
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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.
|
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Non-inferiority performance threshold
Временное ограничение: 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.
|
Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Workflow turnaround time
Временное ограничение: From intraoperative diagnosis to final paraffin pathology confirmation, up to 30 days after surgery.
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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.
|
|
Accuracy for invasive versus non-invasive/minimally invasive adenocarcinoma-spectrum lesions.
Временное ограничение: 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
Временное ограничение: 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.
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From intraoperative diagnosis to final paraffin pathology confirmation, up to 30 days after surgery.
|
|
Specificity
Временное ограничение: 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.
|
Другие показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Diagnostic accuracy (ROC-AUC)
Временное ограничение: 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
Временное ограничение: 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.
|
From intraoperative diagnosis to final paraffin pathology confirmation, up to 30 days after surgery.
|
|
Performance in biopsy or small-tissue specimens
Временное ограничение: 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.
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From intraoperative diagnosis to final paraffin pathology confirmation, up to 30 days after surgery.
|
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Diagnostic Failure Rate
Временное ограничение: 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.
|
|
False Positive Rate
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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.
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Соавторы и исследователи
Здесь вы найдете людей и организации, участвующие в этом исследовании.
Спонсор
Публикации и полезные ссылки
Лицо, ответственное за внесение сведений об исследовании, добровольно предоставляет эти публикации. Это может быть что угодно, связанное с исследованием.
Общие публикации
- 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.
Даты записи исследования
Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.
Изучение основных дат
Начало исследования (Действительный)
3 июля 2026 г.
Первичное завершение (Оцененный)
30 октября 2026 г.
Завершение исследования (Оцененный)
30 ноября 2026 г.
Даты регистрации исследования
Первый отправленный
22 июня 2026 г.
Впервые представлено, что соответствует критериям контроля качества
26 июня 2026 г.
Первый опубликованный (Действительный)
2 июля 2026 г.
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
4 сентября 2026 г.
Последнее отправленное обновление, отвечающее критериям контроля качества
2 сентября 2026 г.
Последняя проверка
1 сентября 2026 г.
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Дополнительные соответствующие термины MeSH
- Новообразования по локализации
- Новообразования
- Заболевания дыхательных путей
- Легочные заболевания
- Новообразования дыхательных путей
- Грудные новообразования
- Новообразования легких
- Следственные методы
- Клинические лабораторные методы
- Диагностические методы и процедуры
- Диагноз
- Цитологические методы
- Гистологические методы
- Методы гистоцитологической подготовки
- Криоультрамикротомия
- Микротомия
- Замороженные срезы
Другие идентификационные номера исследования
- FastLung
- 2025SZ1002 (Другой номер гранта/финансирования: Foundation of Shanghai Key Laboratory of Thoracic Tumor Biotherapy)
Планирование данных отдельных участников (IPD)
Планируете делиться данными об отдельных участниках (IPD)?
НЕТ
Описание плана 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.
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Нет
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
Нет
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .