Menu
Recruiting NCT05943262

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

Observational Brain Tumor Brain Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: mesoscale nonlinear optical microscope.
Who it may be relevant to
Registry conditions: Brain Tumor, Brain Cancer. Basic parameters: from 20 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Taiwan
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Interventions

  • 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.

Primary outcome measures

  • Develop a standard whole-mount tissue processing protocol [Time frame: 3 years]
  • Obtain images from H&E and IHC stained brain tumor tissues by nonlinear optical microscopy [Time frame: 3 years]
Secondary outcome measures (1)
  • Distinguish between normal tissue and brain tumor and determine the extent and grade of the brain tumors [Time frame: 3 years]

Eligibility criteria

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

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Case-only

Study locations

Taiwan · 1 center
  • Department of Surgery, National Taiwan University Hospital and College of Medicine, Nation — Taipei

Identifiers

NCT: NCT05943262 · 202302070RIND

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗