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

July 12, 2024 updated by: National Taiwan University Hospital
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Control human lung tissues (normal human lung tissues)
Diagnostic test: mesoscale nonlinear optical gigascope
An nonlinear optical microscope with ultra-large field of view and ultra-high resolution.
Diagnostic test: Fluorescence microscope
An optical microscope used to examine the fluorescence signal from stained tissues.
Cancerous human lung tissues
Diagnostic test: mesoscale nonlinear optical gigascope
An nonlinear optical microscope with ultra-large field of view and ultra-high resolution.
Diagnostic test: Fluorescence microscope
An optical microscope used to examine the fluorescence signal from stained tissues.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Utilize rapid digital pathology for biomarker detection and 3D pathology in lung cancer.
Time Frame: 1 year
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.
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
National Taiwan University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 15, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 20, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 4, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 12, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 15, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 12, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 202405132RINE

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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