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

NCT06497686 | Not Yet Recruiting

• 1 other identifier: 202405132RINE
• Study Type: observational
• Target: 300
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Lung Cancer; Intraoperative Pathology; 3D Pathology; Immunochemistry Staining

Outcome Measures

Primary Outcomes (1)

• Evaluate the feasibility of replacing frozen section pathology with rapid digital pathology diagnosis.

  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.

  1 years

Secondary Outcomes (1)

• Utilize rapid digital pathology for biomarker detection and 3D pathology in lung cancer.

  1 year

Study Arms (2)

Control human lung tissues (normal human lung tissues)

Diagnostic Test: mesoscale nonlinear optical gigascope; Diagnostic Test: Fluorescence microscope

Cancerous human lung tissues

Diagnostic Test: mesoscale nonlinear optical gigascope; Diagnostic Test: Fluorescence microscope

Interventions

mesoscale nonlinear optical gigascope DIAGNOSTIC_TEST

An nonlinear optical microscope with ultra-large field of view and ultra-high resolution.

Cancerous human lung tissues; Control human lung tissues (normal human lung tissues)

Fluorescence microscope DIAGNOSTIC_TEST

An optical microscope used to examine the fluorescence signal from stained tissues.

Cancerous human lung tissues; Control human lung tissues (normal human lung tissues)

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Following standard surgical procedures for lung cancer tumor resection, the investigators will directly obtain tissue from the post-operative specimens. Without affecting pathological diagnosis, staging, or the assessment of surgical safety margins, the investigators will collect tissue samples measuring approximately 0.5-2.0 cm x 0.5-2.0 cm x 0.3-2.0 cm from the lung cancer/tumor and the surrounding normal tissue or the junction between the tumor and its surrounding normal tissue. These samples will be used for microscopic imaging system detection of lung cancer/tumor tissue. This process, being different from the tissue sent for intraoperative pathological examination, will not affect subsequent diagnosis and treatment.

You may qualify if:

• (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.

You may not qualify if:

• (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.

Sponsors & Collaborators

• National Taiwan University Hospital: lead

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Central Study Contacts

Min-Shu Hsieh, PhD

CONTACT

(02)23123456; ms hsieh065@gmail.com

Yao-Chen Tseng, Master

CONTACT

(02)33661552; opiuy1234567@yahoo.com.tw

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 20, 2024
• First Posted: July 12, 2024
• Study Start: July 15, 2024
• Primary Completion: June 30, 2025
• Study Completion: December 31, 2025
• Last Updated: July 15, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share