Femtosecond Laser Imaging / Lung Cancer / Frozen Section Diagnosis · Observational Study

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 · September 4, 2026

Preliminary Why this matters to you Expert discussion

Early or partial results. Treat as a signal, not a conclusion.

AI Summary

This is a registry record for a recruiting prospective observational study designed to test whether femtosecond laser imaging combined with AI can match frozen section diagnosis for intraoperative lung pathology. No results are posted in this registry record; the study is active and enrollment is ongoing.

What was studied

Observational. Lung Cancer; age from 18 Years; to 90 Years. Intervention: Patients undergoing intraoperative pulmonary nodule diagnos…. Compared with: Standard frozen section diagnosis.. n = 294. 5 sites: China.

Key findings

Safety

Safety was not reported in the material analysed. Check the source before drawing any conclusion about harm.

Who this may help

The source did not state who this applies to in practice.

Plain-language summary

This is a registry record for a recruiting observational study with no results posted; it describes planned diagnostic methodology without outcome data, efficacy estimates, or comparisons to frozen section.

Study design

As stated by the source record.

MethodsCohort model. Prospective time perspective. Primary outcome measure: Non-inferiority performance threshold (assessed at From intraoperative diagnosis to final paraffin pathology confirmation, up to 3…)

DesignObservational

PopulationLung Cancer; age from 18 Years; to 90 Years

Sample size294

InterventionPatients undergoing intraoperative pulmonary nodule diagnos…

ComparatorStandard frozen section diagnosis.

Setting5 sites: China

Reported figures

Quoted from the source exactly as published.

Planned enrollment294

Primary outcome measureNon-inferiority performance threshold, intraoperative diagnosis to final paraffin pathology confirmation, up to 30 days after surgery

Study phaseObservational

Caveats

Results are not yet reported in this registry record; study is actively recruiting.
No efficacy, sensitivity, specificity, or non-inferiority margin data are available.
No outcome comparisons between femtosecond laser imaging and frozen section are provided.
Study design is observational; diagnostic imaging results were stated not to guide intraoperative clinical decision-making.

Evidence assessment

Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.

Study design

moderate

Prospective, multicentre, parallel-workflow, non-inferiority framework; observational, not randomized.

Directness

strong

Direct comparison of femtosecond laser imaging versus frozen section against paraffin pathology reference standard.

Consistency

insufficient

No results reported in this registry record; consistency cannot be assessed.

Risk of bias

moderate

Prospective design and blinded reference standard mitigate bias; observational status and lack of randomisation limit control.

Sample adequacy

moderate

Estimated 294 participants enrolled; adequate for non-inferiority hypothesis, but actual enrollment and completion unknown.

What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.

Source abstract

Registry record from ClinicalTrials.gov (NCT07681245). This is a study registration, not published results. Lead sponsor: Shanghai Chest Hospital. Recruitment status: RECRUITING. Study type: OBSERVATIONAL. Enrollment: 294 participants (ESTIMATED). Conditions: Lung Cancer. Interventions: DIAGNOSTIC_TEST: Femtosecond Laser Imaging; DIAGNOSTIC_TEST: Frozen Section Diagnosis. Primary outcome measures: Non-inferiority performance threshold , From intraoperative diagnosis to final paraffin pathology confirmation, up to 30 days after surgery.. Brief 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. 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.

Follow from this

Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.

Femtosecond Laser ImagingShanghai Chest HospitalNCT07681245Lung CancerFrozen Section Diagnosis