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临床试验/NCT05943262
NCT05943262招募中不适用

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

National Taiwan University Hospital1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2023年5月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
100
试验地点
1
主要终点
Develop a standard whole-mount tissue processing protocol

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Retrospective

入排标准

年龄范围
20 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

结局指标

主要结局

Develop a standard whole-mount tissue processing protocol

时间窗: 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.

Obtain images from H&E and IHC stained brain tumor tissues by nonlinear optical microscopy

时间窗: 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).

次要结局

  • Distinguish between normal tissue and brain tumor and determine the extent and grade of the brain tumors(3 years)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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