Evaluation of cCeLL-Ex Vivo Confocal Microscopy for Real-time Brain Tumor Diagnosis

VPIX Medical285 enrolled

Overview

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 operative time and increasing staffing demands. Confocal Laser Fluorescence Microscopy (cCeLL - Ex vivo) acquires real-time, high-resolution fluorescence images of resected tissue and therefore may serve as a rapid alternative or adjunct to frozen sections. This prospective, multi-center study was designed to systematically assess the clinical performance of cCeLL - Ex vivo during brain-tumor surgery.

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. Secondary Objectives Compare diagnostic turnaround time between cCeLL - Ex vivo and frozen section. Evaluate tumor-type classification accuracy for each modality. Determine the average number of images required for definitive cCeLL - Ex vivo interpretation. Quantify overall diagnostic performance of cCeLL - Ex vivo using the area under the ROC curve (AUC).

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

285

Conditions

Benign Brain Tumor Malignant Brain Tumor

Eligibility

Sex: ALLMin age: 19 Years

Medical Language ↔ Plain English

Inclusion Criteria Specimens and images used in this study must meet all of the following criteria: 1. Tissue obtained from male or female patients aged 19 years or older. 2. Tissue collected from patients scheduled for neurosurgical resection of a suspected brain tumor. 3. 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: 1. Emergency cases where informed consent could not be obtained before surgery. 2. Specimens with significant hemorrhage, affecting image quality. 3. Small biopsy specimens that do not meet the required size for imaging. 4. 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. 5. Cases deemed inappropriate for the study by the principal investigator or study staff due to ethical concerns or potential impact on study results. 6. Patients undergoing multiple surgeries at the same site.

Locations (4)

St. Michael's Hospital

Toronto, Ontario, Canada

Korea University Anam Hospital

Seoul, South Korea

Samsung Medical Center

Seoul, South Korea

Seoul National University Hospital

Seoul, South Korea

Outcomes

Primary Outcomes

Clinical Sensitivity for Tumor Detection (Specimen-level)

The diagnostic results of cCeLL - Ex vivo imaging interpretation by experts and frozen section examination for 283 tumor specimens are presented below.

Time frame: From neurosurgical resection to permanent pathology (≈ 4 weeks)

Clinical Specificity for Tumor Detection (Specimen-level)

The diagnostic results of cCeLL - Ex vivo imaging interpretation by experts and frozen section examination for 39 normal specimens are as follows

Time frame: From neurosurgical resection to permanent pathology (≈ 4 weeks)

Evaluation of cCeLL-Ex Vivo Confocal Microscopy for Real-time Brain Tumor Diagnosis

Overview

Conditions

Interventions

Eligibility

Locations (4)

Outcomes

Primary Outcomes