cCeLL - Ex Vivo (Confocal Fluorescence Endomicroscopy) for Intraoperative Brain Tumor Diagnosis

Study Overview
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Brief Summary
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The goal of this clinical trial is to determine if cCeLL imaging is as accurate as standard biopsy practices for brain tumor surgeries. The main question[s] it aims to answer are: Is it as accurate as standard biopsy practices? Can it be performed faster than standard biopsy practices? Participants will consent to having their tumor tissue assessed by both cCeLL and standard biopsy procedures. There are no additional participation requirements beyond the tumor removal surgery.

Detailed Description
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The usual practice for imaging brain tumor tissue during this type of operation, is to remove tissue from a suspicious lesion and send the tissue to the pathology department where pathologists perform a test called frozen section. The frozen section test cools the tissue to give a diagnosis of the tissue sample (e.g., cancerous or normal tissue). This process may take up to 40 minutes to perform and uses a lot of resources within the hospital. The operation can only be finished after this report is available to the surgeon. After the surgery, the tissue is assessed by pathology with a test called permanent section which can give more details about the tissue assessment. Permanent section results are not available until after the surgery is complete. VPIX Medical Inc. has developed a system to image brain tumor tissue for the purpose of making a diagnosis (clinical decision) during the operation. This system uses Confocal Laser Endomicroscopy to image the removed tissue during the operation. This may be able to replace current standard 'frozen section analysis', which would decrease the resources needed to image the tissue, and provide faster results to the surgeon during the operation. The investigators are performing this study to determine if this type of imaging is as accurate as frozen section and if it can be performed faster. The tissue samples that are being assessed by the study device will be removed as part of a participant's normal surgery. This study will compare the results of the study device and the frozen section results. During the participant's surgery, only the standard test results will be used to make decisions. The images generated by cCeLL device will also be stored in a secure server outside of Canada, for the duration of the study. These images will be de-identified to protect participant privacy, and will be used to create a scientific repository.

Official Title
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A Prospective, Multi-centered, Assessor-blinded Clinical Performance Study to Evaluate the Sensitivity and Specificity of the Proposed Cell/Tissue Histopathology Image Processor cCeLL - Ex Vivo (Confocal Fluorescence Endomicroscopy) for Intraoperative Brain Tumor Diagnosis

Conditions
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Benign Brain Tumor, Malignant Brain Tumor

Intervention / Treatment
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* Diagnostic Test: cCeLL Ex Vivo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The biological specimens (hereafter referred to as 'tissue') and/or images to be used in this trial must be collected from patients who satisfy all of the following inclusion criteria: Male or female patients, ≥ 19 years of age. Patient is suspected to have a brain tumor and has been scheduled for neurosurgery with a potential tumor resection. Patient is willing and able to provide informed consent and understand its content. Exclusion Criteria: Tissue and/or images to be used in this trial must be collected from patients who do not meet any of the following exclusion criteria: Patient has undergone several surgeries on lesion of interest.

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Patients already scheduled for brain tumor surgery<br>The biological specimens (hereafter referred to as 'tissue') and/or images to be used in this trial must be collected from patients who are male or female and ≥ 19 years of age, and the patient is suspected to have a brain tumor and has been scheduled for neurosurgery with a potential tumor resection. There will be up to three (3) tissue sample types assessed for each participant: 1- center-of-tumor, 2- normal tissue (collected from inevitable standard resection), and 3- margin tissue. Tissues will be removed as part of the standard neurosurgical procedure. Resected tissue will be cleaned, stained, and imaged ex-vivo using cCeLL. Image recordings of sample tissue using cCeLL - Ex vivo are taken and the obtained data is stored. | Diagnostic Test: cCeLL Ex Vivo<br>* Neoplastic brain tissue biopsied from participant will be visualized, and images will be captured using cCeLL - Ex vivo.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| cCeLL Ex Vivo and Frozen Section Agreement | Agreement between cCeLL Ex vivo and frozen section reported as the sensitivity and specificity outcomes of cCeLL Ex vivo. | Perioperative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of imaging and analysis duration of cCeLL Ex vivo compared to frozen section | Time from the beginning of imaging to the completion of analysis | 0 to 6 months post-operation | 
| Time required to diagnose cCeLL Ex vivo imaging | Time required by the blinded assessor reach a diagnosis. | 0 to 1 month post-operation | 
| The total number of non-diagnostic cCeLL Ex-vivo images. | Reported as a percentage. Number of non-diagnostic images divided by the total number of images taken | 1 month post-operation | 
| Number of images required to diagnose cCeLL imaging | Number of images required by the blinded assessor reach a diagnosis. | 1 month post-operation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Brain Tumor, Brain Tumor Surgery, Cancer Surgery, Brain Tumor Resection, Biopsy, Digital Biopsy, Frozen Section