Status:
TERMINATED
Evaluation of cCeLL-Ex Vivo Confocal Microscopy for Real-time Brain Tumor Diagnosis
Lead Sponsor:
VPIX Medical
Collaborating Sponsors:
Unity Health Toronto
Korea University Anam Hospital
Conditions:
Benign Brain Tumor
Malignant Brain Tumor
Eligibility:
All Genders
19+ years
Phase:
NA
Brief Summary
Intra-operative evaluation of residual brain tumor currently relies on frozen-section histopathology, which typically requires 20-30 minutes for tissue processing and interpretation, prolonging operat...
Detailed Description
Primary Objective Demonstrate non-inferiority of cCeLL - Ex vivo versus frozen-section histopathology in terms of clinical sensitivity and specificity for intra-operative brain-tumor diagnosis. Seco...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- Specimens and images used in this study must meet all of the following criteria:
- Tissue obtained from male or female patients aged 19 years or older.
- Tissue collected from patients scheduled for neurosurgical resection of a suspected brain tumor.
- Tissue obtained from patients capable of understanding and signing the informed consent form.
- Exclusion Criteria
- Specimens and images that meet any of the following criteria will be excluded from the study:
- Emergency cases where informed consent could not be obtained before surgery.
- Specimens with significant hemorrhage, affecting image quality.
- Small biopsy specimens that do not meet the required size for imaging.
- Poor-quality images that do not meet study criteria, including:
- Low-quality cCeLL - Ex vivo images.
- Non-diagnostic cCeLL - Ex vivo images of the tumor core.
- Cases deemed inappropriate for the study by the principal investigator or study staff due to ethical concerns or potential impact on study results.
- Patients undergoing multiple surgeries at the same site.
Exclusion
Key Trial Info
Start Date :
January 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 27 2024
Estimated Enrollment :
285 Patients enrolled
Trial Details
Trial ID
NCT06098248
Start Date
January 1 2023
End Date
November 27 2024
Last Update
December 15 2025
Active Locations (4)
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1
St. Michael's Hospital
Toronto, Ontario, Canada, M5B 1W8
2
Korea University Anam Hospital
Seoul, South Korea
3
Samsung Medical Center
Seoul, South Korea
4
Seoul National University Hospital
Seoul, South Korea