Record Voxel Rate Nonlinear Optical Microscope to Unravel Brain Connectome and Signaling-Establish Reliably Electrophysiological Readouts From Human-induced Pluripotent Stem Cells (hiPSCs)-Derived Cerebral Organoids and Surgically Dissected Human Live Brains

August 19, 2024 updated by: National Taiwan University Hospital
The research aims to establish a big database of multiple kinds of brain tissues and prove the relevance of human brain tissue models and hiPSCs-derived organoid models.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
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

Brain diseases are very difficult diseases to treat, and when developing related medical cures for saving lives, however, it is difficult to obtain examining samples, especially like normal brain tissue since it is necessary to preserve the brain tissue of patients to ensure its functionality. Among the numerous brain diseases, there are many diseases that combine surgery, chemotherapy, and immunotherapy in treatment. For example, for brain tumors, surgery is the most important treatment that can effectively prolong the survival time of patients. Numerous neurological functions, tumors generated in such important organs, require careful judgment of resection strategy in surgical treatment. In addition to achieving complete tumor resection, subsequent chemotherapy and immunotherapy are also important factors to improve prognosis. Traditionally, the neurosurgeon's experience and various preoperative examinations are used to judge the type and distribution of the disease, which may lead to inconsistent results due to different personal experiences. The current methods that can be used clinically to help improve the integrity of resection (such as intraoperative fluorochrome and intraoperative magnetic resonance imaging) are relatively indirect methods of judgment, but it is hard to directly know the detailed information of the disease before surgery, and the assessment results of formalin-fixed paraffin-embedded (FFPE) section through the standard operation of pathological procedures are used to formulate drug treatment strategies, which may greatly affect the prognosis of patients. According to the current intraoperative cryopathology, there are many brain tumors that cannot be classified easily by it. When searching the literature, there are also few related studies that try to solve this problem, but in addition to the insufficient sample size, it is also impossible to acquire appropriate conclusions due to the limited number of samples. Therefore, through this study, we want to implement optical microscopy and electrophysiological analysis system to capture images and electrophysiological signals of some remaining brain diseased tissues after surgical resection, and compare the acquired datas with the results obtained from human brain organoid tissues. Eventually, construct a large database of brain tissue can also verify whether human brain organoids can completely compare with real human brain samples can truly improve the medical operation.

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.
Interventional

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.
500

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

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

Study Locations

  • Taiwan
      • Taipei, Taiwan
        • Recruiting
        • Department of Surgery, National Taiwan University Hospital and College of Medicine, National Taiwan University
        • Contact:

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

Description

Inclusion Criteria:

1. Patients older than the age of 18 with diagnosis of brain disease (both newly-diagnosed or recurrent) who are suitable and willing to receive resection surgery.

Exclusion Criteria:

  1. Patients who cannot give consent to participate in the study.
  2. The tumor samples failed to give a conclusive pathological diagnosis by standard pathological workflow.
  3. Patients who only receives biopsy surgery rather than resection surgery.
  4. Significant post-irradiation effect or radiation necrosis reported in the pathological examination.

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

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
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.
Experimental: Multiphoton microscopy
Device: Multiphoton microscope
Multiphoton microscope acquires high-resolution image based on nonlinear optics and can be used for detect biological specimens.
Experimental: Electrophysiological system
Device: Electrophysiological system
Electrophysiological system is used for examining voltage variation in biological samples. And multiphoton microscopy is a common type of nonlinear optical microscope.

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
Acquire neuronal structual (image frame) results of different brain regions
Time Frame: 3 years
By interpreting the microscopic images of different brain regions' tissues , an attempt is made to understand the structure of brain disease tissues (via cell morphology, microvessels, etc).
3 years
Acquire electrophysiological readout (voltage amplitude, mV) datas of different brain regions
Time Frame: 3 years
By interpreting the neuron electric reactive datas, an attempt is made to know the neuronal activity (via detecting voltage amplitude change) between multiple neurons.
3 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
To conduct imaging for multiple types of human brain tissues and construct the neuron image database
Time Frame: 3 years
Accumulating the microscopic images and neuron electrosiological signals, the image database of normal and diseased neuron reaction can be constructed.
3 years

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 (Actual)

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.
May 1, 2023

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.
December 31, 2026

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, 2026

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 18, 2023

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.
June 18, 2023

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.
June 27, 2023

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.
August 21, 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.
August 19, 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.
May 1, 2024

More Information

Terms related to this study

Keywords

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.
  • 202302097RIND

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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