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

November 19, 2025 updated by: VPIX Medical

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.

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Actual)

285

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5B 1W8
        • St. Michael's Hospital
  • South Korea
      • Seoul, South Korea
        • Korea University Anam Hospital
      • Seoul, South Korea
        • Samsung Medical Center
      • Seoul, South Korea
        • Seoul National University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Diagnostic test: cCeLL - Ex vivo
Neoplastic brain tissue biopsied from participant will be visualized, and images will be captured using cCeLL - Ex vivo.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical Sensitivity for Tumor Detection (Specimen-level)
Time Frame: From neurosurgical resection to permanent pathology (≈ 4 weeks)
The diagnostic results of cCeLL - Ex vivo imaging interpretation by experts and frozen section examination for 283 tumor specimens are presented below.
From neurosurgical resection to permanent pathology (≈ 4 weeks)
Clinical Specificity for Tumor Detection (Specimen-level)
Time Frame: From neurosurgical resection to permanent pathology (≈ 4 weeks)
The diagnostic results of cCeLL - Ex vivo imaging interpretation by experts and frozen section examination for 39 normal specimens are as follows
From neurosurgical resection to permanent pathology (≈ 4 weeks)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comparison of imaging and analysis duration of cCeLL - Ex vivo compared to frozen section
Time Frame: Perioperative
Time from the beginning of imaging to the completion of analysis
Perioperative
Time required to diagnose cCeLL - Ex vivo imaging
Time Frame: Perioperative
Time required by the blinded assessor reach a diagnosis.
Perioperative
The total number of non-diagnostic cCeLL - Ex vivo images.
Time Frame: Perioperative
Reported as a percentage. Number of non-diagnostic images divided by the total number of images taken
Perioperative
Number of images required to diagnose cCeLL imaging
Time Frame: Perioperative
Number of images required by the blinded assessor reach a diagnosis.
Perioperative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

VPIX Medical

Collaborators

Samsung Medical Center
Seoul National University Hospital
Unity Health Toronto
Korea University Anam Hospital

Investigators

  • Principal Investigator: Sunit Das, MD,MMSc,PhD, Unity Health- St. Michael's Hospital
  • Study Director: Shin-Hyuk Kang, MD,MMSc,PhD, Korea University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2023

Primary Completion (Actual)

November 27, 2024

Study Completion (Actual)

November 27, 2024

Study Registration Dates

First Submitted

October 5, 2023

First Submitted That Met QC Criteria

October 18, 2023

First Posted (Actual)

October 24, 2023

Study Record Updates

Last Update Posted (Estimated)

December 15, 2025

Last Update Submitted That Met QC Criteria

November 19, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • cCell_Ex vivo-01
  • Republic of Korea (Other Identifier: VPIX Medical Inc.)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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