An observational study in Lung Cancer, sponsored by Shanghai Chest Hospital. Recruiting at 5 sites in China. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2026-10-26.
Sponsored by Shanghai Chest Hospital · Observational
Among 46 studies in Lung Neoplasms by Shanghai Chest Hospital — 24 open to participants now, 24 under way, none of them phase 3. Lung Neoplasms · Shanghai Chest Hospital.
Among the 46 studies in Lung Neoplasms by Shanghai Chest Hospital, this one is one of 6 that started in 2026, is one of 9 observational ones, reaches primary completion later than 11 of the 23 other live ones, and was the 43rd registered.
5,422 studies on the registry are indexed under Lung Neoplasms; 1,346 are open to participants now.
Browse Lung Neoplasms studies →24 of the 46 studies in Lung Neoplasms by Shanghai Chest Hospital are open now, in 1 country. Recruiting first, the newest first:
Shanghai Chest Hospital · Sites in China
Shanghai Chest Hospital · Sites in China
Shanghai Chest Hospital · Sites in China
Shanghai Chest Hospital · Sites in China
Shanghai Chest Hospital · Sites in China
By country, each count listing its studies:
Of the 996 Lung Neoplasms studies recruiting now, 683 (69%) set no upper age limit and 142 (14%) stop at 75 or younger; 45 take children under 18; 142 take healthy volunteers.
This study: 18 Years to 90 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
46 studies; the count open now beside each. This study's row is marked.
First in 2013; this study’s year is marked. 6 started in 2026.
This study's planned enrollment of 294 is above the median of 200 across 1,434 observational studies indexed under Lung Neoplasms.
Median enrollment 80 across the 37 interventional studies, 294 across the 9 observational. Of the 4 that completed or were terminated, 1 (25%) have results posted.
This tab as a report to print or save as PDF → With an account.
Shanghai Chest Hospital is the lead sponsor of 198 studies on the registry; 98 are open to participants now.
5 of the studies in Lung Neoplasms by Shanghai Chest Hospital that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06503744Shanghai Chest HospitalTransthoracic vs Transbronchial Radiofrequency Ablation for Lung Cancer | 2026-12 |
| NCT07830095Shanghai Chest Hospital5G-Enabled Remote Robotic-Assisted Bronchoscopy-Guided Cryoablation for Pulmonary Malignancies | 2026-12-31 |
| NCT05494021Shanghai Chest HospitalChina Lung Cancer Screening (CLUS) Study Version 3.0 | 2026-12-31 |
| NCT07806981Shanghai Chest Hospital18G Ultrafine Cryoablation Needle for Coaxial Biopsy and Cryoablation of Pulmonary Nodules | 2027-04-01 |
| NCT06936644Shanghai Chest HospitalA Multicenter, Single-arm Phase II Study to Evaluate the Efficacy and Safety of Fulzerasib (IBI351) in Combination With Ivonescimab (AK-112) in First-line Treatment of Advanced or Metastatic Non-small Cell Lung Cancer Patients With KRAS G12C Mutation | 2027-04-30 |
Among the 46 studies in Lung Neoplasms by Shanghai Chest Hospital, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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.
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.
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.
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.
Exclusion Criteria:
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.
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.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Diagnostic Test: Femtosecond Laser Imaging · Diagnostic Test: Frozen Section Diagnosis
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.
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.
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.
Time frame: From intraoperative diagnosis to final paraffin pathology confirmation, up to 30 days after surgery.
Workflow turnaround time
To compare workflow turnaround time for FLI + Fast Lung and routine frozen-section pathology.
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.
To evaluate the accuracy of Fast Lung 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
To estimate the sensitivity of Fast Lung for malignant lesions using FFPE histopathology as the reference standard.
Time frame: 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.
Time frame: From intraoperative diagnosis to final paraffin pathology confirmation, up to 30 days after surgery.
Diagnostic accuracy (ROC-AUC)
The area under the receiver operating characteristic curve (ROC-AUC) will be used to assess the overall diagnostic accuracy of FLI-FastLung model in etermination of the benign or malignant of surgical specimens compared with final paraffin pathology as the reference standard.
Time frame: From intraoperative diagnosis to final paraffin pathology confirmation, up to 30 days after surgery.
Performance of histological subtype diagnostic
The performance of the FLI-FastLung model in distinguishing LUAD from LUSC will be evaluated using final paraffin pathology as the reference standard. Diagnostic performance will be quantified by area under the ROC curve (ROC-AUC), overall accuracy, sensitivity, and specificity.
Time frame: From intraoperative diagnosis to final paraffin pathology confirmation, up to 30 days after surgery.
Performance in biopsy or small-tissue specimens
The performance of the FLI-FastLung model in biopsy or small tissue specimens will be assessed using final paraffin pathology as the reference standard. Diagnostic performance will be quantified by area under the ROC curve (ROC-AUC), overall accuracy, sensitivity, and specificity.
Time frame: From intraoperative diagnosis to final paraffin pathology confirmation, up to 30 days after surgery.
Diagnostic Failure Rate
Diagnostic failure rate refers to the proportion of cases in which the FLI-FastLung system is unable to generate a valid histological classification result. A diagnostic failure is defined as the absence of a final output due to inadequate image quality, insufficient tissue input, or system processing failure.
Time frame: From intraoperative diagnosis to final paraffin pathology confirmation, up to 30 days after surgery.
False Positive Rate
False positive rate will be calculated as the proportion of cases incorrectly classified as positive by the FLI-FastLung model when compared with final paraffin pathology as the reference standard. The result will be derived from a confusion matrix and expressed as a percentage (%).
Time frame: From intraoperative diagnosis to final paraffin pathology confirmation, up to 30 days after surgery.
False Negative Rate
False negative rate will be calculated as the proportion of cases incorrectly classified as negative by the FLI-FastLung model when compared with final paraffin pathology as the reference standard. The result will be derived from a confusion matrix and expressed as a percentage (%).
Time frame: From intraoperative diagnosis to final paraffin pathology confirmation, up to 30 days after surgery.
Heatmap-pathology concordance
Concordance between FastLung-generated heatmaps and corresponding pathological tumor regions will be evaluated using spatial overlap metrics. The primary measurement will be the Dice similarity coefficient (DSC) between model-generated heatmap regions and manually annotated pathological tumor areas. Results will be expressed as a continuous score ranging from 0 to 1.
Time frame: From intraoperative diagnosis to final paraffin pathology confirmation, up to 30 days after surgery.
Plan to share: 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.
Started Jul 2026 (actual). Primary completion is estimated for Oct 2026, 3 months after the start.
Of 591 non-industry observational studies under Lung Neoplasms, half reached primary completion within 65 months of starting (the median), counting those still running; a quarter within 25 and three quarters within 162. This study's planned 3 months is below that.
Counting every sponsor, half of 681 studies reached it within 57 months; a quarter within 25 and three quarters within 135.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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