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

NCT ID: NCT06497686

Last Updated: 2024-07-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-07-15

Study Completion Date

2025-12-31

Brief Summary

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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

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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.

Conditions

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Lung Cancer Intraoperative Pathology 3D Pathology Immunochemistry Staining

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Control human lung tissues (normal human lung tissues)

mesoscale nonlinear optical gigascope

Intervention Type DIAGNOSTIC_TEST

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

Fluorescence microscope

Intervention Type DIAGNOSTIC_TEST

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

Cancerous human lung tissues

mesoscale nonlinear optical gigascope

Intervention Type DIAGNOSTIC_TEST

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

Fluorescence microscope

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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mesoscale nonlinear optical gigascope

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

Intervention Type DIAGNOSTIC_TEST

Fluorescence microscope

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Taiwan University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Central Contacts

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Min-Shu Hsieh, PhD

Role: CONTACT

(02)23123456 ext. 263155

Yao-Chen Tseng, Master

Role: CONTACT

(02)33661552

Other Identifiers

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202405132RINE

Identifier Type: -

Identifier Source: org_study_id

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