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

July 4, 2023 updated by: National Taiwan University Hospital
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

100

Phase

  • 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 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

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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.

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: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: mesoscale nonlinear optical microscope + whole-mount H&E & IHC staining protocol
Device: mesoscale nonlinear optical microscope
The mesoscale nonlinear optical microscope based on the principles of nonlinear optics and computed-algorithms can acquire large-area image within few minutes.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
3 years
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).
3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Distinguish between normal tissue and brain tumor and determine the extent and grade of the brain tumors
Time Frame: 3 years
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).
3 years

Collaborators and Investigators

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

Sponsor

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)

May 1, 2023

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

June 18, 2023

First Submitted That Met QC Criteria

July 4, 2023

First Posted (Actual)

July 13, 2023

Study Record Updates

Last Update Posted (Actual)

July 13, 2023

Last Update Submitted That Met QC Criteria

July 4, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 202302070RIND

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.

Clinical Trials on Brain Cancer

Clinical Trials on mesoscale nonlinear optical microscope

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Saudi Arabia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe