Trials / Terminated
TerminatedNCT06098248
Evaluation of cCeLL-Ex Vivo Confocal Microscopy for Real-time Brain Tumor Diagnosis
A Prospective, Multi-centered, Assessor-blinded Clinical Performance Study to Evaluate the Sensitivity and Specificity of the cCeLL-Ex Vivo Device for Intraoperative Brain Tumor Diagnosis.
- Status
- Terminated
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 285 (actual)
- Sponsor
- VPIX Medical · Industry
- Sex
- All
- Age
- 19 Years
- Healthy volunteers
- Not accepted
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 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.
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. 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).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DIAGNOSTIC_TEST | cCeLL - Ex vivo | Neoplastic brain tissue biopsied from participant will be visualized, and images will be captured using cCeLL - Ex vivo. |
Timeline
- Start date
- 2023-01-01
- Primary completion
- 2024-11-27
- Completion
- 2024-11-27
- First posted
- 2023-10-24
- Last updated
- 2025-12-15
- Results posted
- 2025-12-15
Locations
4 sites across 2 countries: Canada, South Korea
Source: ClinicalTrials.gov record NCT06098248. Inclusion in this directory is not an endorsement.