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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