Clinical trial · Observational
The Application of Rapid Fresh Digital Pathology on the Diagnosis and Biomarker Testing of Lung Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Through this project, the rapid staining process will be optimized for ex-vivo human lung specimens and integrate advanced ex-vivo mesoscale nonlinear optical gigascope. Initially, this will provide rapid digital pathological diagnosis during lung cancer surgeries. This will help achieve the dual goals of precise and efficient complete resection of lung cancer tissues while preserving tissue functionality. The application of this technology aims to provide higher-quality medical services for patients suffered from lung cancers.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| 3D Pathology | — | UNRESOLVED | — |
| Immunochemistry Staining | — | UNRESOLVED | — |
| Intraoperative Pathology | — | UNRESOLVED | — |
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Fluorescence microscope | Diagnostic Test | — | UNRESOLVED |
| mesoscale nonlinear optical gigascope | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Control human lung tissues (normal human lung tissues)
- interventionNames
- Diagnostic Test: mesoscale nonlinear optical gigascope
- Diagnostic Test: Fluorescence microscope
- label
- Cancerous human lung tissues
- interventionNames
- Diagnostic Test: mesoscale nonlinear optical gigascope
- Diagnostic Test: Fluorescence microscope
Primary outcomes (1)
- measure
- Evaluate the feasibility of replacing frozen section pathology with rapid digital pathology diagnosis.
- timeFrame
- 1 years
- description
- Obtain a portion of specimens and directly perform rapid H\&E staining. Then, place the edge of the cut surface of the specimen flat on the microscope objective for observation. The same specimen will then undergo the standard histological staining process in the pathology department for comparative analysis. Another portion of the specimen will be processed using the pathology department's standard frozen section procedure for comparative analysis. In this study, the investigators will acquire the pathological tissue images (with multiple distinct structures like nuclear atypia, vessels, vesicles, and so on) in those images via rapid-fresh-pathology, frozen pathology and formalin-fixed embedded pathology. And the analysis of the number of abnormal cells, irregular vesicles and tumor structures will be conducted to provide pathologists information to compare and distinguish whether it is normal or not.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
Show eligibility criteria text
Inclusion Criteria: * (1) Adults aged 20 and above. * (2) Patients diagnosed with lung cancer or lung tumors, scheduled for surgical resection. A total of 300 patients are expected to be included. Exclusion Criteria: * (1) Patients unable to provide consent. (e.g., inability to speak, inability to communicate in Chinese, etc.). * (2) Patients for whom a definitive pathological diagnosis cannot be established. * (3) Patients suitable only for biopsy and not for surgical resection. * (4) Exclude specimens that are too small or lesions that are too small to retain extra tissue.
References
Publications (0)
Data not yet available