Clinical trial NCT05943262: Record Voxel Rate Nonlinear Optical Microscope to Unravel Brain Connectome and Signaling
Official title: Record Voxel Rate Nonlinear Optical Microscope to Unravel Brain Connectome and Signaling
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Brain Tumor
Brain Cancer
Keywords: brain tumor
brain cancer
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2023-07-13
Enrollment: 100
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

Brief 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.

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:

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.

Primary outcomes:
measure: Develop a standard whole-mount tissue processing protocol
timeFrame: 3 years
measure: Obtain images from H&E and IHC stained brain tumor tissues by nonlinear optical microscopy
timeFrame: 3 years
Secondary outcomes:
measure: Distinguish between normal tissue and brain tumor and determine the extent and grade of the brain tumors
timeFrame: 3 years
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Department of Surgery, National Taiwan University Hospital and College of Medicine, National Taiwan University
Study officials:
References: