Brain TumorNCT05943262
Record Voxel Rate Nonlinear Optical Microscope to Unravel Brain Connectome and Signaling
An observational study of Brain Tumor and Brain Cancer, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
The research aims to develop a novel pathological technology, including rapid whole-mount tissue H\&E \& IHC staining protocol and high-resolution nonlinear optical microscopy imaging system, to intraoperatively assess brain tumor grade, types and other biological parameters. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Brain Tumor, Brain Cancer
- What is being tested?
- mesoscale nonlinear optical microscope
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 May 2023to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: Patients older than the age of 20 with diagnosis of brain tumor (both newly-diagnosed or recurrent) who are suitable and willing to receive resection surgery will be recruited.
Who may be able to join
- 1. Patients older than the age of 20 with diagnosis of brain tumor (both newly-diagnosed or recurrent) who are suitable and willing to receive resection surgery.
Who cannot join
- Patients who cannot give consent to participate in the study.
- The tumor samples failed to give a conclusive pathological diagnosis by standard pathological workflow.
- Patients who only receives biopsy surgery rather than resection surgery.
- Significant post-irradiation effect or radiation necrosis reported in the pathological examination.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site, 1 recruiting
- Recruiting
Department of Surgery, National Taiwan University Hospital and College of Medicine, National Taiwan University
Taipei
Kuo-Chuan Wang, +886-23123456 ext. 263155, wang081466@yahoo.com.tw
About this study
The research aims to develop a novel pathological technology, including rapid whole-mount tissue H\&E \& IHC staining protocol and high-resolution nonlinear optical microscopy imaging system, to intraoperatively assess brain tumor grade, types and other biological parameters.
Read the detailed description
Brain tumors, especially like glioma, the infiltrative growth pattern resulted in an indistinct margin against normal brain tissues. Surgery is currently the most effective method in prolonging patient's survival, the extent of tumor resection is therefore crucial to the overall outcome. Distinguishing the tumor type and grading can help neurosurgeons plan the intraoperative surgical strategies to cure the suffered patients. Feasible solutions to improve the extent of resections including fluorescence-guided surgery and intraoperative MR imaging are relatively indirect to judge the completeness of tumor resection and its margin; considering means like Moh's surgery performed in the dermatological practice, though it is reasonable to look at the resection proportion by pathological interpretation, it is very time consuming. Besides, many kinds of brain tumors can't be classified only by the outcomes of frozen pathology. There are several related studies trying to solve the problem, but the judgment criteria is not sufficient to meet the standard of modern pathological diagnosis. The research aims to acquire images by optical microscopy from both H\&E and IHC stained tissues, and to compare those images with slides obtained by standard pathological workflow in order to achieve accurate and rapid assessment of tumor categories and grading.
- Conditions
- Brain Tumor, Brain Cancer
- Being tested
- mesoscale nonlinear optical microscope
- Keywords
- brain tumor, brain cancer
- Medical subject headings
- Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mesoscale nonlinear optical microscopeDevice
The mesoscale nonlinear optical microscope based on the principles of nonlinear optics and computed-algorithms can acquire large-area image within few minutes.
| Study group | Role | What they receive |
|---|---|---|
| mesoscale nonlinear optical microscope + whole-mount H&E & IHC staining protocol | Not described Receives: Device: mesoscale nonlinear optical microscope |
What is being measured
The primary outcome is the main question the study is designed to answer.
Develop a standard whole-mount tissue processing protocol
In this research, the investigators will try to create a standard staining protocol to perform rapid whole-mount H\&E and IHC staining on surgical brain tumor specimens, so that the cell morphology (ex: cell shape, cell size, etc) and cell types (ex: astrocytes, oligodendrocytes, T-cells, B-cells, etc) in the images of those tissues can be observed via nonlinear optical microscopy, and the treatment strategy can be set based on subtyping and grading the brain tumors by the pathologists.
Measured: 3 years
Obtain images from H&E and IHC stained brain tumor tissues by nonlinear optical microscopy
Images of brain tumor specimens will be taken by nonlinear optical microscopy and a image database of brain tumors can be created (ex: cell shape, cell size and cell density of different cells in human brain tissues).
Measured: 3 years
Secondary outcomes (1)
Distinguish between normal tissue and brain tumor and determine the extent and grade of the brain tumors
By interpreting the images acquired from nonlinear optical microscope of the two staining methods and the images obtained by bright field microscope for pathologists with standard procedures, an attempt is made to distinguish between normal tissue and brain tumor and determine the extent and grade of those brain tumors (depending on tumor characteristics, such as hypercellularity, microvascular proliferation, necrosis, etc).
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2023
- Study start1 May 2023
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain TumorStudies 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
- Retrospective
- Enrolment
- 100 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
- NCT05943262
- Sponsor's protocol ID
- 202302070RIND
- Status last verified
- May 2024
- First submitted
- 18 Jun 2023
- Last updated
- 21 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Record Voxel Rate Nonlinear Optical Microscope to Unravel Brain Connectome and Signaling
- ClinicalTrials.gov ID
- NCT05943262
- Acronym / sponsor ID
- 202302070RIND
- Conditions
- Brain Tumor, Brain Cancer
- Keywords
- brain tumor, brain cancer
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 1 May 2023 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 13 Jul 2023 (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.
The research aims to develop a novel pathological technology, including rapid whole-mount tissue H\&E \& IHC staining protocol and high-resolution nonlinear optical microscopy imaging system, to intraoperatively assess brain tumor grade, types and other biological parameters.
Detailed description
Brain tumors, especially like glioma, the infiltrative growth pattern resulted in an indistinct margin against normal brain tissues. Surgery is currently the most effective method in prolonging patient's survival, the extent of tumor resection is therefore crucial to the overall outcome. Distinguishing the tumor type and grading can help neurosurgeons plan the intraoperative surgical strategies to cure the suffered patients. Feasible solutions to improve the extent of resections including fluorescence-guided surgery and intraoperative MR imaging are relatively indirect to judge the completeness of tumor resection and its margin; considering means like Moh's surgery performed in the dermatological practice, though it is reasonable to look at the resection proportion by pathological interpretation, it is very time consuming. Besides, many kinds of brain tumors can't be classified only by the outcomes of frozen pathology. There are several related studies trying to solve the problem, but the judgment criteria is not sufficient to meet the standard of modern pathological diagnosis. The research aims to acquire images by optical microscopy from both H\&E and IHC stained tissues, and to compare those images with slides obtained by standard pathological workflow in order to achieve accurate and rapid assessment of tumor categories and grading.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| mesoscale nonlinear optical microscope + whole-mount H&E & IHC staining protocol | – | Device: mesoscale nonlinear optical microscope |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients older than the age of 20 with diagnosis of brain tumor (both newly-diagnosed or recurrent) who are suitable and willing to receive resection surgery will be recruited.
Key inclusion criteria (1 listed)
- 1. Patients older than the age of 20 with diagnosis of brain tumor (both newly-diagnosed or recurrent) who are suitable and willing to receive resection surgery.
Key exclusion criteria (4 listed)
- Patients who cannot give consent to participate in the study.
- The tumor samples failed to give a conclusive pathological diagnosis by standard pathological workflow.
- Patients who only receives biopsy surgery rather than resection surgery.
- Significant post-irradiation effect or radiation necrosis reported in the pathological examination.
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 microscopeThe mesoscale nonlinear optical microscope based on the principles of nonlinear optics and computed-algorithms can acquire large-area image within few minutes. | Device | mesoscale nonlinear optical microscope + whole-mount H&E & IHC staining protocol |
Primary outcome
Develop a standard whole-mount tissue processing protocol
Time frame: 3 years
In this research, the investigators will try to create a standard staining protocol to perform rapid whole-mount H\&E and IHC staining on surgical brain tumor specimens, so that the cell morphology (ex: cell shape, cell size, etc) and cell types (ex: astrocytes, oligodendrocytes, T-cells, B-cells, etc) in the images of those tissues can be observed via nonlinear optical microscopy, and the treatment strategy can be set based on subtyping and grading the brain tumors by the pathologists.
Obtain images from H&E and IHC stained brain tumor tissues by nonlinear optical microscopy
Time frame: 3 years
Images of brain tumor specimens will be taken by nonlinear optical microscopy and a image database of brain tumors can be created (ex: cell shape, cell size and cell density of different cells in human brain tissues).
1 secondary outcome
Distinguish between normal tissue and brain tumor and determine the extent and grade of the brain tumors
Time frame: 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2024.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Brain Tumor and Brain Cancer, run by National Taiwan University Hospital at 1 site in Taiwan.
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 1 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: looking for participants now, as of the sponsor's last update on 21 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kuo-Chuan Wang (+886-23123456 ext. 263155, wang081466@yahoo.com.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Develop a standard whole-mount tissue processing protocol (time frame: 3 years). The study lists 2 primary outcomes in all. 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 21 Aug 2024; AzTrials last refreshed its copy on 6 Nov 2026.