The Application of Rapid Fresh Digital Pathology on the Diagnosis and Biomarker Testing of Lung Cancer

Not yet recruiting

• Conditions: Lung Cancer; 3D Pathology; Intraoperative Pathology; Immunochemistry Staining
• Interventions: Diagnostic Test: mesoscale nonlinear optical gigascope; Diagnostic Test: Fluorescence microscope

• Registration Number: NCT06497686
• Lead Sponsor: National Taiwan University Hospital

Brief Summary

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.

Detailed Description

Frozen section can provide rapid diagnosis during the operation, and its information is very important for surgeons to make decisions for the operative methods, especially for patients whose clinical conditions or lesions sites are inappropriate for biopsy. The frozen section procedure requires a pathological laboratory, a skilled technician, and an experienced pathologist. Not all pathological laboratories can perform the frozen section procedure. The frozen section can also cause frozen artifacts and tissue loss especially for small biopsy samples. In this study rapid fresh digital pathology combining the rapid whole-mount hematoxylin-eosin (H\&E) tissue staining (the-RTS) method and optical imaging via mesoscale nonlinear optical gigascope (mNLOG) will be used to obtain digital images with ultra-high resolution of resected lung specimens. These images will be analyzed by experienced pathologists and compared with H\&E-stained slides from traditional frozen section procedures to see if the rapid fresh digital pathology can be used as an alternative method for intraoperative frozen section procedure.

Moreover, the potential to use rapid fresh digital pathology in the detection of lung cancer biomarkers (including low-grade or high-grade patterns, invasive or in situ lesions, and STAS) and three-dimensional pathology will also be evaluated.

Study Timeline

• Status Verified: 2024-06
• Study First Submitted: 2024-06-20
• Study First Submitted QC: 2024-07-04
• Study First Posted: 2024-07-12
• Last Update Submitted: 2024-07-12
• Study Start: 2024-07-15
• Last Update Posted: 2024-07-15
• Primary Completion: 2025-06-30
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 300

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cancerous human lung tissues	Fluorescence microscope	-
Control human lung tissues (normal human lung tissues)	mesoscale nonlinear optical gigascope	-
Cancerous human lung tissues	mesoscale nonlinear optical gigascope	-
Control human lung tissues (normal human lung tissues)	Fluorescence microscope	-

Primary Outcome Measures

Name	Time	Method
Evaluate the feasibility of replacing frozen section pathology with rapid digital pathology diagnosis.	1 years	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.

Secondary Outcome Measures

Name	Time	Method
Utilize rapid digital pathology for biomarker detection and 3D pathology in lung cancer.	1 year	Obtain specimens for testing with rapid immunohistochemical (IHC) staining process and used for the three-dimensional reconstruction of lung tissue structure. First, label and stain the specimen using antibodies, then observe it under the mesoscale optical microscope or the fluorescence microscope. The same specimen will then undergo the standard histological staining process in the pathology department for comparative analysis. In this study, the image data will be reconstructed using 3D reconstruction technology to present the three-dimensional structure (for example: vessels, vesicles and so on) of the lung tissue specimen. This will be used for three-dimensional digital pathology research on tumor grading and growth patterns.(including low-grade or high-grade patterns, invasive or in situ lesions, and STAS) and three-dimensional pathology will also be evaluated.