Viewing Study NCT06497686



Ignite Creation Date: 2024-07-17 @ 11:42 AM
Last Modification Date: 2024-10-26 @ 3:34 PM
Study NCT ID: NCT06497686
Status: NOT_YET_RECRUITING
Last Update Posted: 2024-07-15
First Post: 2024-06-20

Brief Title: The Application of Rapid Fresh Digital Pathology on the Diagnosis and Biomarker Testing of Lung Cancer
Sponsor: National Taiwan University Hospital
Organization: National Taiwan University Hospital

Study Overview

Official Title: The Application of Rapid Fresh Digital Pathology on the Diagnosis and Biomarker Testing of Lung Cancer
Status: NOT_YET_RECRUITING
Status Verified Date: 2024-06
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
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 HE 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 HE-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 Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None