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Trial Title:
cCeLL - Ex Vivo (Confocal Fluorescence Endomicroscopy) for Intraoperative Brain Tumor Diagnosis
NCT ID:
NCT06098248
Condition:
Benign Brain Tumor
Malignant Brain Tumor
Conditions: Official terms:
Neoplasms
Brain Neoplasms
Conditions: Keywords:
Brain Tumor
Brain Tumor Surgery
Cancer Surgery
Brain Tumor Resection
Biopsy
Digital Biopsy
Frozen Section
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Diagnostic
Masking:
None (Open Label)
Intervention:
Intervention type:
Diagnostic Test
Intervention name:
cCeLL - Ex vivo
Description:
Neoplastic brain tissue biopsied from participant will be visualized, and images will be
captured using cCeLL - Ex vivo.
Arm group label:
Patients already scheduled for brain tumor surgery
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.
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.
Criteria for eligibility:
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.
Gender:
All
Minimum age:
19 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
St. Michael's Hospital
Address:
City:
Toronto
Zip:
M5B 1W8
Country:
Canada
Contact:
Last name:
Sunit Das, PhD, MA, BA
Phone:
416-864-5548
Email:
sunit.das@unityhealth.to
Facility:
Name:
Korea University Anam Hospital
Address:
City:
Seoul
Country:
Korea, Republic of
Facility:
Name:
Samsung Medical Center
Address:
City:
Seoul
Country:
Korea, Republic of
Facility:
Name:
Seoul National University Hospital
Address:
City:
Seoul
Country:
Korea, Republic of
Start date:
June 2024
Completion date:
June 2025
Lead sponsor:
Agency:
VPIX Medical
Agency class:
Industry
Collaborator:
Agency:
Unity Health Toronto
Agency class:
Other
Collaborator:
Agency:
Korea University Anam Hospital
Agency class:
Other
Collaborator:
Agency:
Samsung Medical Center
Agency class:
Other
Collaborator:
Agency:
Seoul National University Hospital
Agency class:
Other
Source:
VPIX Medical
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06098248
