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

Not Applicable

Not yet recruiting

• Conditions: Benign Brain Tumor; Malignant Brain Tumor

• Registration Number: NCT06098248
• Lead Sponsor: VPIX Medical

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.

Study Timeline

• Study First Submitted: 2023-10-05
• Study First Submitted QC: 2023-10-18
• Study First Posted: 2023-10-24
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-15
• Last Update Posted: 2024-05-17
• Study Start: 2024-06
• Primary Completion: 2025-01
• Study Completion: 2025-06

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 160

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Time required to diagnose cCeLL - Ex vivo imaging	Perioperative	Time required by the blinded assessor reach a diagnosis.
Number of images required to diagnose cCeLL imaging	Perioperative	Number of images required by the blinded assessor reach a diagnosis.
Comparison of imaging and analysis duration of cCeLL - Ex vivo compared to frozen section	Perioperative	Time from the beginning of imaging to the completion of analysis
The total number of non-diagnostic cCeLL - Ex vivo images.	Perioperative	Reported as a percentage. Number of non-diagnostic images divided by the total number of images taken

Trial Locations

Locations (4)

St. Michael's Hospital; 🇨🇦 Toronto, Ontario, Canada

Korea University Anam Hospital; 🇰🇷 Seoul, Korea, Republic of

Samsung Medical Center; 🇰🇷 Seoul, Korea, Republic of

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of