Clinical trial · Interventional
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.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Delays in specimen recruitment have increased costs and strained resources, risking study validity. To maintain ethical and scientific integrity, the study will be terminated early.
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Benign Brain Tumor | Benign Brain Neoplasm | ALIAS | 0.90 |
| Malignant Brain Tumor | Malignant Brain Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| cCeLL - Ex vivo | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Patients already scheduled for brain tumor surgery
- 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.
- interventionNames
- Diagnostic Test: cCeLL - Ex vivo
Primary outcomes (2)
- measure
- Clinical Sensitivity for Tumor Detection (Specimen-level)
- timeFrame
- From neurosurgical resection to permanent pathology (≈ 4 weeks)
- description
- The diagnostic results of cCeLL - Ex vivo imaging interpretation by experts and frozen section examination for 283 tumor specimens are presented below.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 19 Years
Show eligibility criteria text
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.
References
Publications (14)
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- BACKGROUNDFerlay J, Ervik M, Lam F, Colombet M, Mery L, Piñeros M, et al. Global Cancer Observatory: Cancer Today. Lyon: International Agency for Research on Cancer; 2020 (https://gco.iarc.fr/today, accessed February 2021).
- BACKGROUNDIndustryARC. Oncology Market - Forecast (2020 - 2025). 2020.
- BACKGROUNDMat Zin AA, Zulkarnain S. Diagnostic Accuracy of Cytology Smear and Frozen Section in Glioma. Asian Pac J Cancer Prev. 2019 Feb 26;20(2):321-325. doi: 10.31557/APJCP.2019.20.2.321. PMID 30803189
- BACKGROUNDMauna Kea Technologies. Cellvizio: Real-time in vivo cellular imaging platform. 2021:Brochure. Available at: http://www.cellvizio.net/uploads/media/media_pdf/0001/03/MKT-132-EN-Cellvizio%20Web%20Brochure.pdf