Femtosecond laser imaging with FastLung AI for intraoperative lung diagnosis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This multicenter, prospective study compares two diagnostic methods on paired fresh lung tissue from planned lung surgeries. Each specimen is split, with one half undergoing standard frozen section and the other half analyzed by femtosecond laser imaging using FastLung AI. The diagnostic results are then compared to the final paraffin-embedded pathology, which serves as the truth. The femtosecond laser results are for research and do not influence surgical decisions. The trial uses a non-inferiority design to determine if the laser-imaging approach performs at least as well as frozen sections in intraoperative settings.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Preoperative imaging suggests a pulmonary nodule, pulmonary space-occupying lesion, or suspected pulmonary tumor lesion.
2. The participant is scheduled to undergo pulmonary wedge resection, segmentectomy, lobectomy, or other pulmonary surgery.
3. Fresh lung tissue specimens can be obtained intraoperatively for femtosecond laser imaging.
4. Intraoperative frozen section diagnosis is planned to assess the nature of the tumor lesion.
5. Corresponding postoperative paraffin-embedded pathological diagnosis can be obtained.
6. The participant or the participant's legally authorized representative has signed the written informed consent form.
7. 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:

1. The intraoperative specimen is insufficient and cannot simultaneously meet the requirements for routine clinical pathological diagnosis and research-related testing.
2. The specimen shows severe carbonization, necrosis, compression, contamination, or improper preservation, and the investigator determines that effective imaging cannot be completed.
3. The femtosecond laser imaging specimen cannot be matched with the corresponding lesion assessed by final paraffin pathology.
4. Final paraffin-embedded pathological diagnosis cannot be obtained.
5. The participant withdraws informed consent.
6. Other conditions that, in the opinion of the investigator, make the participant unsuitable for this study.

Where it's running

• Huadong Hospital
  Shanghai, Shanghai Municipality, China Recruiting
• Shanghai Chest Hospital
  Shanghai, Shanghai Municipality, China Recruiting
• Tongji Hospital
  Shanghai, Shanghai Municipality, China Recruiting
• Tongren Hospital
  Shanghai, Shanghai Municipality, China Recruiting
• Dongfang Hospital
  Shanghai, Shanghai Municipality, China Not yet recruiting

Study contacts

• Study coordinator: Xinghua Cheng, Dr. PhD.
• Email: xinhuacheng@sjtu.edu.cn
• Phone: 17701681215

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.