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

National Taiwan University

Status

Not yet enrolling

Conditions

Intraoperative Pathology

Immunochemistry Staining

Lung Cancer

3D Pathology

Treatments

Diagnostic Test: Fluorescence microscope

Diagnostic Test: mesoscale nonlinear optical gigascope

Study type

Observational

Funder types

Other

Identifiers

NCT06497686

202405132RINE

Details and patient eligibility

About

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.

Full 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.

Enrollment

300 estimated patients

Sex

All

Ages

20+ years old

Volunteers

No Healthy Volunteers

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.