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

NCT06098248 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 285

Last updated 2025-12-15

Study results available
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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.

Conditions

  • Benign Brain Tumor
  • Malignant Brain Tumor

Interventions

DIAGNOSTIC_TEST

cCeLL - Ex vivo

Neoplastic brain tissue biopsied from participant will be visualized, and images will be captured using cCeLL - Ex vivo.

Sponsors & Collaborators

  • Unity Health Toronto

    collaborator OTHER

  • Korea University Anam Hospital

    collaborator OTHER

  • Samsung Medical Center

    collaborator OTHER

  • Seoul National University Hospital

    collaborator OTHER

  • VPIX Medical

    lead INDUSTRY

Principal Investigators

  • Sunit Das, MD,MMSc,PhD · Unity Health- St. Michael's Hospital

  • Shin-Hyuk Kang, MD,MMSc,PhD · Korea University

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-01-01
Primary Completion
2024-11-27
Completion
2024-11-27

Countries

  • Canada
  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06098248 on ClinicalTrials.gov