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Not yet recruitingNCT07799038Updated Sep 2, 2026

A Multicenter Prospective Study Evaluating the Diagnostic Performance of Femtosecond Laser Label-Free Imaging Combined With Artificial Intelligence for Predicting High-Risk Pathological Features in Lung Cancer

An observational study in Lung Cancer (Diagnosis), sponsored by Shanghai Zhongshan Hospital. Not yet recruiting. Per ClinicalTrials.gov, last updated 2026-09-02.

Sponsored by Shanghai Zhongshan Hospital · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
333
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 11 studies in Lung Neoplasms by Shanghai Zhongshan Hospital — 6 open to participants now, 6 under way, none of them phase 3. Lung Neoplasms · Shanghai Zhongshan Hospital.

Started
2026
with 2 others
Observational
7 of 11
4 open now
Registered
9th of 11
by date

Among the 11 studies in Lung Neoplasms by Shanghai Zhongshan Hospital, this one is one of 3 that started in 2026, is one of 7 observational ones, and was the 9th registered.

By phase

11 studies; the count open now beside each. This study's row is marked.

Observationalthis study7 · 4 open
No phase2 · 1 open
Other kind1 · 0 open
Phase 21 · 1 open

By the year they started

First in 2011; this study’s year is marked. 3 started in 2026.

Size and results

Median enrollment 190 across the 3 interventional studies, 334 across the 8 observational. Of the 2 that completed or were terminated, 0 (0%) have results posted.

Watch this landscapeDownload CSVWith an account: a weekly mail of what changed among 11 studies in Lung Neoplasms by Shanghai Zhongshan Hospital, or all of them as a file.
02

Study summary

To investigate the diagnostic performance of Femtosecond Laser Label-Free Imaging combined with artificial intelligence for predicting high-risk pathological features in lung cancer

03

Conditions studied

  • Lung Cancer (Diagnosis)

Keywords

  • Lung cancer
  • FLI
04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Sampling method
Non-probability sample

Study population

Lung cancer patients undergoing pulmonary resection.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Pulmonary nodules detected by clinical imaging with an indication for surgical resection.
  2. Patient agrees to and is planned for pulmonary (partial) resection.
  3. Resected specimens are suitable for FLI imaging.
  4. Written obtained from the patient or legal representative.
  5. Patients undergoing pulmonary (partial) resection at our hospital during this study.

Exclusion criteria

Exclusion Criteria:

  1. Insufficient sample.
  2. Specimen with crushing, contamination, or improper preservation, precluding valid imaging as judged by the investigator.
  3. Inability to obtain matched pathology results corresponding to FLI images.
  4. Inability to obtain final pathological diagnosis.
  5. Other conditions deemed by the investigator as unsuitable for study participation.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
333 participants (estimated)
Patient registry
No

Interventions

  • Diagnostic testFemtosecond Laser Label-Free Imaging Combined with Artificial Intelligence.

    Femtosecond Laser Label-Free Imaging Combined with Artificial Intelligence. The diagnostic results will be blinded to both the physicians (including all clinicians involved in the patient's diagnostic and treatment process, such as surgeons and pathologists) and the patient, and the diagnostic results will NOT affect the original treatment plan.

06

What researchers measure

Primary outcomes

  1. The primary endpoint is the accuracy of the FLI combined with the AI model in predicting regional lymph node metastasis status in lung cancer, evaluated using postoperative pathology results as the reference standard.

    Time frame: through study completion, an average of 2 year

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 2, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07799038
Responsible party
Sponsor
First posted
Sep 2, 2026
Start date
Sep 1, 2026 (estimated)
Primary completion
Aug 31, 2028 (estimated)
Completion
Aug 31, 2028 (estimated)
Last update
Sep 2, 2026
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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