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NCT07681245Recruiting

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.

Source: ClinicalTrials.gov · Last updated 26 Oct 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Observational
Enrollment
294 (estimated)
First submitted
22 Jun 2026
Start date
3 Jul 2026
Primary completion date
30 Oct 2026
Lead sponsor
Shanghai Chest Hospital
Diseases
Lung cancer
NCT number
NCT07681245

What you commit to

  • Study type: Observational
  • Planned participants: 294
  • From 3 Jul 2026 to the primary completion date, 30 Oct 2026
  • 5 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • Other conditions that, in the opinion of the investigator, make the participant unsuitable for this study.

Other

  • 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.

Who the study is looking for

  • 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.

Age in the registry: 18 years to 90 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (5)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Dongfang Hospital
Coordinator of this site? Confirm its status
ShanghaiChinaNot yet recruiting
Tongji Hospital
Coordinator of this site? Confirm its status
ShanghaiChinaRecruiting
Shanghai Chest Hospital
Coordinator of this site? Confirm its status
ShanghaiChinaRecruiting
Tongren Hospital
Coordinator of this site? Confirm its status
ShanghaiChinaRecruiting
Huadong Hospital
Coordinator of this site? Confirm its status
ShanghaiChinaRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.