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

Sponsor

VPIX Medical (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT06098248

Collaborator

Unity Health Toronto (Other), Korea University Anam Hospital (Other), Samsung Medical Center (Other), Seoul National University Hospital (Other)

160

Enrollment

Locations

Arm

Anticipated Duration (Months)

Patients Per Site

2.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Benign Brain Tumor Malignant Brain Tumor	Diagnostic Test: cCeLL Ex Vivo	N/A

Detailed Description

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

160 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

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

Anticipated Study Start Date :

Jan 1, 2024

Anticipated Primary Completion Date :

Jan 1, 2025

Anticipated Study Completion Date :

Jun 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Patients already scheduled for brain tumor surgery 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 Neoplastic brain tissue biopsied from participant will be visualized, and images will be captured using cCeLL - Ex vivo.

Arm

Intervention/Treatment

Experimental: Patients already scheduled for brain tumor surgery

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

Neoplastic brain tissue biopsied from participant will be visualized, and images will be captured using cCeLL - Ex vivo.

Outcome Measures

Primary Outcome Measures

cCeLL Ex Vivo and Frozen Section Agreement [Perioperative]
Agreement between cCeLL Ex vivo and frozen section reported as the sensitivity and specificity outcomes of cCeLL Ex vivo.

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

19 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	St. Michael's Hospital	Toronto	Ontario	Canada	M5B 1W8
2	Korea University Anam Hospital	Seoul		Korea, Republic of
3	Samsung Medical Center	Seoul		Korea, Republic of
4	Seoul National University Hospital	Seoul		Korea, Republic of

Sponsors and Collaborators

VPIX Medical
Unity Health Toronto
Korea University Anam Hospital
Samsung Medical Center
Seoul National University Hospital

Investigators

Principal Investigator: Sunit Das, MD, PhD, MA, BA, Unity Health- St. Michael's Hospital
Study Director: Shin-Hyuk Kang, MD, M.M.Sc, PhD, Korea University