Lung CancerNCT06497686
The Application of Rapid Fresh Digital Pathology on the Diagnosis and Biomarker Testing of Lung Cancer
An observational study of Lung Cancer and Intraoperative Pathology, run by National Taiwan University Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Lung Cancer, Intraoperative Pathology, 3D Pathology
- What is being tested?
- mesoscale nonlinear optical gigascope and Fluorescence microscope
- How many people
- 300 participants
- Where
- No sites listed yet
- Study dates
- 15 Jul 2024to 31 Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- (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.
Who cannot join
- (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.
Trial locations and contacts
No sites are listed yet.
About this study
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.
Read the 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.
- Being tested
- mesoscale nonlinear optical gigascope, Fluorescence microscope
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mesoscale nonlinear optical gigascopeDiagnostic test
An nonlinear optical microscope with ultra-large field of view and ultra-high resolution.
Fluorescence microscopeDiagnostic test
An optical microscope used to examine the fluorescence signal from stained tissues.
| Study group | Role | What they receive |
|---|---|---|
| Control human lung tissues (normal human lung tissues) | Not described Receives: Diagnostic Test: mesoscale nonlinear optical gigascope; Diagnostic Test: Fluorescence microscope | |
| Cancerous human lung tissues | Not described Receives: Diagnostic Test: mesoscale nonlinear optical gigascope; Diagnostic Test: Fluorescence microscope |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 years
Secondary outcomes (1)
Utilize rapid digital pathology for biomarker detection and 3D pathology in lung cancer.
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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2024
- Study start15 Jul 2024 (estimated)
- Primary completion30 Jun 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06497686
- Sponsor's protocol ID
- 202405132RINE
- Status last verified
- Jun 2024
- First submitted
- 20 Jun 2024
- Last updated
- 15 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Application of Rapid Fresh Digital Pathology on the Diagnosis and Biomarker Testing of Lung Cancer
- ClinicalTrials.gov ID
- NCT06497686
- Acronym / sponsor ID
- 202405132RINE
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 15 Jul 2024 (estimated)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 12 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- (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.
Key exclusion criteria (4 listed)
- (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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| mesoscale nonlinear optical gigascopeAn nonlinear optical microscope with ultra-large field of view and ultra-high resolution. | Diagnostic test | Cancerous human lung tissues, Control human lung tissues (normal human lung tissues) |
| Fluorescence microscopeAn optical microscope used to examine the fluorescence signal from stained tissues. | Diagnostic test | Cancerous human lung tissues, Control human lung tissues (normal human lung tissues) |
Primary outcome
Evaluate the feasibility of replacing frozen section pathology with rapid digital pathology diagnosis.
Time frame: 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.
1 secondary outcome
Utilize rapid digital pathology for biomarker detection and 3D pathology in lung cancer.
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Cancer and Intraoperative Pathology, run by National Taiwan University Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Min-Shu Hsieh, PhD ((02)23123456 ext. 263155, ms hsieh065@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate the feasibility of replacing frozen section pathology with rapid digital pathology diagnosis. (time frame: 1 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2024; AzTrials last refreshed its copy on 7 Nov 2026.