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

VPIX Medical

Status: Terminated

Conditions: Malignant Brain Tumor; Benign Brain Tumor

Treatments: Diagnostic Test: cCeLL - Ex vivo

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06098248

cCell_Ex vivo-01

Republic of Korea (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

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).

Enrollment: 285 patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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285 participants in 1 patient group

Patients already scheduled for brain tumor surgery

Experimental group

Description:

Study Arms and Intervention This study compares cCeLL - Ex vivo imaging (test) and frozen section histopathology (control) against permanent section histopathology (reference standard). * Test Arm: Uses confocal laser fluorescence microscopy (CLFM) for real-time imaging of resected tumor tissues, analyzed by blinded pathologists. * Control Arm: Standard H\&E-stained frozen section, requiring tissue processing (30-40 min) for intraoperative diagnosis. The study evaluates diagnostic accuracy, sensitivity, and specificity of cCeLL - Ex vivo imaging.

Treatment:

Diagnostic Test: cCeLL - Ex vivo