Clinical trial NCT06098248: cCeLL - Ex Vivo (Confocal Fluorescence Endomicroscopy) for Intraoperative Brain Tumor Diagnosis
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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Benign Brain Tumor
Malignant Brain Tumor
Keywords: Brain Tumor
Brain Tumor Surgery
Cancer Surgery
Brain Tumor Resection
Biopsy
Digital Biopsy
Frozen Section
Lead sponsor: VPIX Medical
Sponsor class: INDUSTRY
Collaborators: name: Unity Health Toronto
name: Korea University Anam Hospital
name: Samsung Medical Center
name: Seoul National University Hospital
First posted: 2023-10-24
Enrollment: 160
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

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.

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.

Primary outcomes:
measure: cCeLL - Ex vivo and Frozen Section Agreement
timeFrame: Perioperative
Secondary outcomes:
measure: Comparison of imaging and analysis duration of cCeLL - Ex vivo compared to frozen section
timeFrame: Perioperative
measure: Time required to diagnose cCeLL - Ex vivo imaging
timeFrame: Perioperative
measure: The total number of non-diagnostic cCeLL - Ex vivo images.
timeFrame: Perioperative
measure: Number of images required to diagnose cCeLL imaging
timeFrame: Perioperative
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: St. Michael's Hospital
state: Ontario
city: Seoul
country: Korea, Republic of
facility: Korea University Anam Hospital
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Unity Health- St. Michael's Hospital
name: Sunit Das, MD, PhD, MA, BA
role: PRINCIPAL_INVESTIGATOR
affiliation: Korea University
name: Shin-Hyuk Kang, MD, M.M.Sc, PhD
role: STUDY_DIRECTOR
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