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

NCT06098248 | Terminated Results

• 2 other identifiers: cCell_Ex vivo-01Republic of Korea
• Study Type: interventional
• Target: 285
• Locations: 2 countries
• Sites: 4

Brief 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

Keywords

Brain Tumor; Brain Tumor Surgery; Cancer Surgery; Brain Tumor Resection; Biopsy; Digital Biopsy; Frozen Section

Outcome Measures

Primary Outcomes (2)

• Clinical Sensitivity for Tumor Detection (Specimen-level)

  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)

  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)

Study Arms (1)

Patients already scheduled for brain tumor surgery

EXPERIMENTAL

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

Interventions

cCeLL - Ex vivo DIAGNOSTIC_TEST

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

Patients already scheduled for brain tumor surgery

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Specimens and images used in this study must meet all of the following criteria:
• Tissue obtained from male or female patients aged 19 years or older.
• Tissue collected from patients scheduled for neurosurgical resection of a suspected brain tumor.
• Tissue obtained from patients capable of understanding and signing the informed consent form.

You may not qualify if:

• Specimens and images that meet any of the following criteria will be excluded from the study:
• Emergency cases where informed consent could not be obtained before surgery.
• Specimens with significant hemorrhage, affecting image quality.
• Small biopsy specimens that do not meet the required size for imaging.
• 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.
• Cases deemed inappropriate for the study by the principal investigator or study staff due to ethical concerns or potential impact on study results.
• Patients undergoing multiple surgeries at the same site.

Sponsors & Collaborators

• VPIX Medical: lead
• Unity Health Toronto: collaborator
• Korea University Anam Hospital: collaborator
• Samsung Medical Center: collaborator
• Seoul National University Hospital: collaborator

Study Sites (4)

St. Michael's Hospital

Toronto, Ontario, M5B 1W8, Canada

Location

Korea University Anam Hospital

Seoul, South Korea

Location

Samsung Medical Center

Seoul, South Korea

Location

Seoul National University Hospital

Seoul, South Korea

Location

Related Publications (14)

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  BACKGROUND

MeSH Terms

Conditions

Brain Neoplasms

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Limitations and Caveats

1. Ex vivo design restricts immediate in vivo application. 2. Single-arm structure limits certain statistical inferences. 3. Learning curve affects imaging time. 4. Results may not fully generalize beyond the study settings. 5. Some data were missing, though at a low rate.

Results Point of Contact

• Title: Min-Jae Jeong
• Organization: VPIX Medical, Inc

clinical@vpixmedical.com

82425350676

Study Officials

• Sunit Das, MD,MMSc,PhD

  Unity Health- St. Michael's Hospital

  PRINCIPAL INVESTIGATOR

• Shin-Hyuk Kang, MD,MMSc,PhD

  Korea University

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: This trial employed an assessor-blinded design. Specifically, the pathologist who interpreted the cCeLL - Ex vivo images had no access to the patient's clinical information, frozen section results, or permanent section results. By ensuring that the individual responsible for cCeLL - Ex vivo image interpretation was blinded to other diagnostic data, the study minimized bias in determining sensitivity and specificity outcomes.
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: * All enrolled participants were assigned to the same intervention (i.e., cCeLL - Ex vivo), with no separate control group or comparator. * 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.

Study Record Dates

• First Submitted: October 5, 2023
• First Posted: October 24, 2023
• Study Start: January 1, 2023
• Primary Completion: November 27, 2024
• Study Completion: November 27, 2024
• Last Updated: December 15, 2025
• Results First Posted: December 15, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

KR (3); CA (1)