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

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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	19 Years and Over
Gender	All

More Inclusion & Exclusion Criteria

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:
1.

Male or female patients, ≥ 19 years of age. 2. Patient is suspected to have a brain tumor and has been scheduled for neurosurgery with a potential tumor resection. 3. 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:
1.

Patient has undergone several surgeries on lesion of interest.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT06098248
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	VPIX Medical
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Sunit Das, MD, PhD, MA, BAShin-Hyuk Kang, MD, M.M.Sc, PhD
Principal Investigator Affiliation	Unity Health- St. Michael's HospitalKorea University
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Industry, Other
Overall Status	Not yet recruiting
Countries	Canada, Korea, Republic of
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Benign Brain Tumor, Malignant Brain Tumor

Additional Details

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.

Arms & Interventions

Arms

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.

Interventions

Diagnostic Test: - cCeLL - Ex vivo

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

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.