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.
2026년 9월 2일 업데이트: 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.
연구 개요
상세 설명
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.
연구 유형
관찰
등록 (추정된)
294
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
- 이름: Xinghua Cheng, Dr. PhD.
- 전화번호: 17701681215
- 이메일: xinhuacheng@sjtu.edu.cn
연구 장소
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Shanghai Municipality
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Shanghai, Shanghai Municipality, 중국, 200030
- 모병
- Shanghai Chest Hospital
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연락하다:
- Yin Li, Dr.
- 전화번호: 8618758824569
- 이메일: liy1398901568@163.com
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Shanghai, Shanghai Municipality, 중국, 200030
- 아직 모집하지 않음
- Dongfang Hospital
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연락하다:
- Weigang Zhao, Dr.
- 전화번호: 8618930170427
- 이메일: zhaowg@163.com
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Shanghai, Shanghai Municipality, 중국, 200030
- 아직 모집하지 않음
- Huadong Hospital
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연락하다:
- Huibiao Zhang, Dr.
- 전화번호: 8613916804033
- 이메일: huibiao_zhang@163.com
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Shanghai, Shanghai Municipality, 중국, 200030
- 아직 모집하지 않음
- Tongji Hospital
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연락하다:
- wenli Wang, Dr.
- 전화번호: 8613761295864
- 이메일: anderson840913@163.com
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Shanghai, Shanghai Municipality, 중국, 200030
- 아직 모집하지 않음
- Tongren Hospital
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연락하다:
- ning Wang, Dr.
- 전화번호: 8618017337120
- 이메일: WN3565@shtrhospital.com
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
아니
샘플링 방법
비확률 샘플
연구 인구
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.
설명
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.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
|---|---|
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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.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Non-inferiority performance threshold
기간: From intraoperative diagnosis to final paraffin pathology confirmation, up to 30 days after surgery.
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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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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Workflow turnaround time
기간: 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.
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Accuracy for invasive versus non-invasive/minimally invasive adenocarcinoma-spectrum lesions.
기간: 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
기간: 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
기간: From intraoperative diagnosis to final paraffin pathology confirmation, up to 30 days after surgery.
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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.
|
기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Diagnostic accuracy (ROC-AUC)
기간: 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
기간: 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
기간: 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.
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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
기간: 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.
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From intraoperative diagnosis to final paraffin pathology confirmation, up to 30 days after surgery.
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False Positive Rate
기간: 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
기간: 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.
|
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Heatmap-pathology concordance
기간: From intraoperative diagnosis to final paraffin pathology confirmation, up to 30 days after surgery.
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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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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
일반 간행물
- 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.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
2026년 7월 3일
기본 완료 (추정된)
2026년 10월 30일
연구 완료 (추정된)
2026년 11월 30일
연구 등록 날짜
최초 제출
2026년 6월 22일
QC 기준을 충족하는 최초 제출
2026년 6월 26일
처음 게시됨 (실제)
2026년 7월 2일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 9월 4일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 9월 2일
마지막으로 확인됨
2026년 9월 1일
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- FastLung
- 2025SZ1002 (기타 보조금/기금 번호: Foundation of Shanghai Key Laboratory of Thoracic Tumor Biotherapy)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
아니요
IPD 계획 설명
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.
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
아니
미국 FDA 규제 기기 제품 연구
아니
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .