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

NCT ID: NCT05943262

Condition: Brain Tumor
Brain Cancer

Conditions: Official terms:
Brain Neoplasms

Conditions: Keywords:
brain tumor
brain cancer

Study type: Observational

Overall status: Recruiting

Study design:

Time perspective: Retrospective

Intervention:

Intervention type: Device
Intervention name: mesoscale nonlinear optical microscope
Description: The mesoscale nonlinear optical microscope based on the principles of nonlinear optics and computed-algorithms can acquire large-area image within few minutes.
Arm group label: mesoscale nonlinear optical microscope + whole-mount H&E & IHC staining protocol

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.

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.

Criteria for eligibility:

Study pop:
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.

Sampling method: Non-Probability Sample
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: 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.

Gender: All

Minimum age: 20 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Department of Surgery, National Taiwan University Hospital and College of Medicine, National Taiwan University

Address:
City: Taipei
Country: Taiwan

Status: Recruiting

Contact:
Last name: Kuo-Chuan Wang

Phone: +886-23123456

Phone ext: 263155
Email: wang081466@yahoo.com.tw

Start date: May 1, 2023

Completion date: December 31, 2026

Lead sponsor:
Agency: National Taiwan University Hospital
Agency class: Other

Source: National Taiwan University Hospital

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05943262

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