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RecruitingNCT05921786Updated Aug 21, 2024

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

An interventional study of Electrophysiological system and Multiphoton microscope in Brain Diseases and Brain Tumor, sponsored by National Taiwan University Hospital. Recruiting at 1 site in Taiwan. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-08-21.

Sponsored by National Taiwan University Hospital · Not applicable, Interventional, and Basic science

From the registry’s dates

  • Started May 2023; still recruiting 3 years 5 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
500
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

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.

Read the 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.

02

Conditions studied

  • Brain Diseases
  • Brain Tumor

Keywords

  • brain diseases, brain tumor
03

In context

Brain Neoplasms

1,960 studies on the registry are indexed under Brain Neoplasms; 516 are open to participants now.

This study's planned enrollment of 500 is above the median of 40 across 1,458 interventional studies indexed under Brain Neoplasms.

Browse Brain Neoplasms studies →

Lead sponsor

National Taiwan University Hospital is the lead sponsor of 2,563 studies on the registry; 569 are open to participants now.

Of its 11 completed or terminated interventional studies of FDA-regulated products, 2 (18%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
500 participants (estimated)

Study arms

  • Experimental
    Multiphoton microscopy

    Device: Multiphoton microscope

  • Experimental
    Electrophysiological system

    Device: Electrophysiological system

Interventions

  • DeviceElectrophysiological system

    Electrophysiological system is used for examining voltage variation in biological samples. And multiphoton microscopy is a common type of nonlinear optical microscope.

  • DeviceMultiphoton microscope

    Multiphoton microscope acquires high-resolution image based on nonlinear optics and can be used for detect biological specimens.

06

What researchers measure

Primary outcomes

  1. Acquire neuronal structual (image frame) results of different brain regions

    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).

    Time frame: 3 years

  2. Acquire electrophysiological readout (voltage amplitude, mV) datas of different brain regions

    By interpreting the neuron electric reactive datas, an attempt is made to know the neuronal activity (via detecting voltage amplitude change) between multiple neurons.

    Time frame: 3 years

Secondary outcomes

  1. To conduct imaging for multiple types of human brain tissues and construct the neuron image database

    Accumulating the microscopic images and neuron electrosiological signals, the image database of normal and diseased neuron reaction can be constructed.

    Time frame: 3 years

07

Study locations

1 of 1 sites recruiting
  • Department of Surgery, National Taiwan University Hospital and College of Medicine, National Taiwan University
    Taipei, Taiwan
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 21, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05921786
Lead sponsor
National Taiwan University Hospital
Responsible party
Sponsor
First posted
Jun 27, 2023
Start date
May 1, 2023
Primary completion
Dec 31, 2026 (estimated)
Completion
Dec 31, 2026 (estimated)
Last update
Aug 21, 2024

Study contacts

Kuo-Chuan Wang
Contact
wang081466@yahoo.com.tw
+886-23123456 ext. 263155
Yao-Chen Tseng
Contact
opiuy1234567@yahoo.com.tw
+886-33661552

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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