Lung CancerNCT07681245
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.
An observational study of Lung Cancer, run by Shanghai Chest Hospital at 5 sites in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Lung Cancer
- What is being tested?
- Femtosecond Laser Imaging and Frozen Section Diagnosis
- How many people
- 294 participants
- Where
- 5 sitesChina
- Study dates
- 3 Jul 2026to 30 Nov 2026
- How long will I take part?
- 30 Days
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
China5 sites, 5 recruiting
- Not yet recruiting
Dongfang Hospital
Shanghai, Shanghai Municipality, 200030
Weigang Zhao, Dr., 8618930170427, zhaowg@163.com
- Recruiting
Huadong Hospital
Shanghai, Shanghai Municipality, 200030
Huibiao Zhang, Dr., 8613916804033, huibiao_zhang@163.com
- Recruiting
Shanghai Chest Hospital
Shanghai, Shanghai Municipality, 200030
Yin Li, Dr., 8618758824569, liy1398901568@163.com
- Recruiting
Tongji Hospital
Shanghai, Shanghai Municipality, 200030
wenli Wang, Dr., 8613761295864, anderson840913@163.com
- Recruiting
Tongren Hospital
Shanghai, Shanghai Municipality, 200030
ning Wang, Dr., 8618017337120, WN3565@shtrhospital.com
About this study
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.
Read the detailed description
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.
- Conditions
- Lung Cancer
- Being tested
- Femtosecond Laser Imaging, Frozen Section Diagnosis
- Keywords
- lung cancer, artificial intelligence, Intraoperative diagnosis
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Femtosecond Laser ImagingDiagnostic test
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.
Frozen Section DiagnosisDiagnostic test
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: Femtosecond Laser Imaging; Diagnostic Test: Frozen Section Diagnosis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Non-inferiority performance threshold
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.
Measured: From intraoperative diagnosis to final paraffin pathology confirmation, up to 30 days after surgery.
Secondary outcomes (4)
Workflow turnaround time
To compare workflow turnaround time for FLI + Fast Lung and routine frozen-section pathology.
Measured: 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.
To evaluate the accuracy of Fast Lung for invasive versus non-invasive/minimally invasive adenocarcinoma-spectrum lesions.
Measured: From intraoperative diagnosis to final paraffin pathology confirmation, up to 30 days after surgery.
Sensitivity
To estimate the sensitivity of Fast Lung for malignant lesions using FFPE histopathology as the reference standard.
Measured: From intraoperative diagnosis to final paraffin pathology confirmation, up to 30 days after surgery.
Specificity
To estimate the specificity of Fast Lung for benign lesions using FFPE histopathology as the reference standard.
Measured: From intraoperative diagnosis to final paraffin pathology confirmation, up to 30 days after surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2026
- Study start3 Jul 2026
- Primary completion30 Oct 2026 (estimated)
- Study completion30 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- More trials run by Shanghai Chest HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 294 participants (estimated)
- Target duration
- 30 Days
Sponsor and investigators
- Lead sponsor
- Shanghai Chest Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Femtosecond Applications and Research (Guangzhou)
- Responsible party
- Principal investigator, Xinghua Cheng, Shanghai Chest Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07681245
- Sponsor's protocol ID
- FastLung
- Other IDs
- 2025SZ1002
- Status last verified
- Oct 2026
- First submitted
- 22 Jun 2026
- Last updated
- 26 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Publications
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.
PubMed 19934776Hollon 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.
PubMed 31907460Lan 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.
PubMed 41402452
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT07681245
- Acronym / sponsor ID
- FastLung
- Conditions
- Lung Cancer
- Keywords
- lung cancer, artificial intelligence, Intraoperative diagnosis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 294 participants (estimated)
- Lead sponsor
- Shanghai Chest HospitalUniversity, hospital or other
- Collaborators
- Femtosecond Applications and Research (Guangzhou)
- Study start
- 3 Jul 2026 (actual)
- Primary completion
- 30 Oct 2026 (estimated)
- Study completion
- 30 Nov 2026 (estimated)
- First posted
- 2 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 30 Days
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients undergoing intraoperative pulmonary nodule diagnosis | – | Diagnostic Test: Femtosecond Laser Imaging, Diagnostic Test: Frozen Section DiagnosisPatients 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. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Femtosecond Laser ImagingFresh 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. | Diagnostic test | Patients undergoing intraoperative pulmonary nodule diagnosis |
| Frozen Section DiagnosisFresh 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. | Diagnostic test | Patients undergoing intraoperative pulmonary nodule diagnosis |
Primary outcome
Non-inferiority performance threshold
Time frame: 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.
4 secondary outcomes
Workflow turnaround time
Time frame: 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.
Time frame: From intraoperative diagnosis to final paraffin pathology confirmation, up to 30 days after surgery.
Sensitivity
Time frame: From intraoperative diagnosis to final paraffin pathology confirmation, up to 30 days after surgery.
Specificity
Time frame: From intraoperative diagnosis to final paraffin pathology confirmation, up to 30 days after surgery.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2026.
- Background: PubMed 19934776Xu 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.
- Background: PubMed 31907460Hollon 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.
- Background: PubMed 41402452Lan 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.
- Individual participant dataSharing planned: No. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Cancer, run by Shanghai Chest Hospital at 5 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xinghua Cheng, Dr. PhD. (17701681215, xinhuacheng@sjtu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Non-inferiority performance threshold (time frame: From intraoperative diagnosis to final paraffin pathology confirmation, up to 30 days after surgery.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07681245, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2026.