Evaluation of cCeLL-Ex Vivo Confocal Microscopy for Real-time Brain Tumor Diagnosis
NCT ID: NCT06098248
Last Updated: 2025-12-15
Study Results
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View full resultsBasic Information
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TERMINATED
NA
285 participants
INTERVENTIONAL
2023-01-01
2024-11-27
Brief Summary
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Detailed Description
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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
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Study Design
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NA
SINGLE_GROUP
* The study's primary purpose was to evaluate the diagnostic performance (sensitivity, specificity) of the investigational device in a single cohort of participants undergoing brain tumor resection.
DIAGNOSTIC
NONE
Study Groups
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Patients already scheduled for brain tumor surgery
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.
cCeLL - Ex vivo
Neoplastic brain tissue biopsied from participant will be visualized, and images will be captured using cCeLL - Ex vivo.
Interventions
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cCeLL - Ex vivo
Neoplastic brain tissue biopsied from participant will be visualized, and images will be captured using cCeLL - Ex vivo.
Eligibility Criteria
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Inclusion 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
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.
19 Years
ALL
No
Sponsors
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Unity Health Toronto
OTHER
Korea University Anam Hospital
OTHER
Samsung Medical Center
OTHER
Seoul National University Hospital
OTHER
VPIX Medical
INDUSTRY
Responsible Party
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Principal Investigators
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Sunit Das, MD,MMSc,PhD
Role: PRINCIPAL_INVESTIGATOR
Unity Health- St. Michael's Hospital
Shin-Hyuk Kang, MD,MMSc,PhD
Role: STUDY_DIRECTOR
Korea University
Locations
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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
Countries
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References
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Amos WB, White JG. How the confocal laser scanning microscope entered biological research. Biol Cell. 2003 Sep;95(6):335-42. doi: 10.1016/s0248-4900(03)00078-9.
BIS Research Inc. Medical market data. Updated 2022. https://blog.bisresearch.com/bis-research-market-insights-quick-bytes
Carl Zeiss Meditec AG. Convivo: Putting in vivo cellular imaging at your fingertips. 2019:Brochure. Available at: https://www.zeiss.com/content/dam/Meditec/ref_master/products/convivo/documents/convivo_brochure.pdf
Chand P, Amit S, Gupta R, Agarwal A. Errors, limitations, and pitfalls in the diagnosis of central and peripheral nervous system lesions in intraoperative cytology and frozen sections. J Cytol. 2016 Apr-Jun;33(2):93-7. doi: 10.4103/0970-9371.182530.
de Martel C, Georges D, Bray F, Ferlay J, Clifford GM. Global burden of cancer attributable to infections in 2018: a worldwide incidence analysis. Lancet Glob Health. 2020 Feb;8(2):e180-e190. doi: 10.1016/S2214-109X(19)30488-7. Epub 2019 Dec 17.
Ferlay 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).
IndustryARC. Oncology Market - Forecast (2020 - 2025). 2020.
Mat 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.
Mauna 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
MAVIG GmbH. Vivascope: Confocal laser scanning microscopy - In vivo histology for cellular level skin analyses in cosmetic research and dermopharmacy. 2019:Brochure. Available at: https://www.vivascope.de/wp-content/uploads/2019/06/Cosmeticbrochure.pdf
Samal S, Kalra R, Sharma J, et al. Comparison between crush/squash cytology and frozen section preparation in intraoperative diagnosis of central nervous system lesions. Oncol J India. 2018;1:25-30.
Tofte K, Berger C, Torp SH, Solheim O. The diagnostic properties of frozen sections in suspected intracranial tumors: A study of 578 consecutive cases. Surg Neurol Int. 2014 Dec 3;5:170. doi: 10.4103/2152-7806.146153. eCollection 2014.
White JG, Amos WB, Fordham M. An evaluation of confocal versus conventional imaging of biological structures by fluorescence light microscopy. J Cell Biol. 1987 Jul;105(1):41-8. doi: 10.1083/jcb.105.1.41.
WHO. Assessing national capacity for the prevention and control of noncommunicable diseases: report of the 2019 global survey. Geneva: World Health Organization; 2020.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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Republic of Korea
Identifier Type: OTHER
Identifier Source: secondary_id
cCell_Ex vivo-01
Identifier Type: -
Identifier Source: org_study_id
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