Record Voxel Rate Nonlinear Optical Microscope to Unravel Brain Connectome and Signaling

NCT05943262 | Recruiting DMC

• 1 other identifier: 202302070RIND
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Brain Tumor; Brain Cancer

Keywords

brain tumor; brain cancer

Outcome Measures

Primary Outcomes (2)

• 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.

  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).

  3 years

Secondary Outcomes (1)

• Distinguish between normal tissue and brain tumor and determine the extent and grade of the brain tumors

  3 years

Study Arms (1)

mesoscale nonlinear optical microscope + whole-mount H&E & IHC staining protocol

Device: mesoscale nonlinear optical microscope

Interventions

mesoscale nonlinear optical microscope DEVICE

The mesoscale nonlinear optical microscope based on the principles of nonlinear optics and computed-algorithms can acquire large-area image within few minutes.

mesoscale nonlinear optical microscope + whole-mount H&E & IHC staining protocol

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• \. 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

Department of Surgery, National Taiwan University Hospital and College of Medicine, National Taiwan University

Taipei, Taiwan

RECRUITING

MeSH Terms

Conditions

Brain Neoplasms

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Central Study Contacts

Kuo-Chuan Wang

CONTACT

+886-23123456; wang081466@yahoo.com.tw

Yao-Chen Tseng

CONTACT

+886-33661552; opiuy1234567@yahoo.com.tw

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 18, 2023
• First Posted: July 13, 2023
• Study Start: May 1, 2023
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: August 21, 2024

Record last verified: 2024-05

Locations

TW (1)