A PROSPECTIVE, SINGLE-CENTERED, ASSESSOR-BLINDED STUDY TO EVALUATE THE CLINICAL EFFICACY OF THE PROPOSED CELL/TISSUE HISTOPATHOLOGY PROCESSOR CCELL (CONFOCAL FLUORESCENCE ENDOMICROSCOPY) FOR INTRAOPERATIVE DIAGNOSIS IN BRAIN TUMORS

NCT07254845 | Not Yet Recruiting Phase 1

• 1 other identifier: cCeLL_II_2025_Cedars
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief Summary

The primary objective of this single-center study is to demonstrate the performance of cCeLL, used in real time, compared to frozen section analysis. The investigational device is intended for use with indocyanine green (ICG) for fluorescence imaging as an aid in the visualization of vessels (micro- and macro-vasculature) blood flow in the cerebrovascular before, during or after cranial diagnostic and therapeutic procedures, such as tumor biopsy and resection, and the images will be immediately transmitted to a single pathologist for real-time evaluation, without influencing the surgical decision-making process. The comparison will be made between the device and the conventional intraoperative histological frozen section analysis of identical brain tissue samples in the same patient. Both methods will be compared in terms of their accuracy using the standard of practice, the final pathological diagnosis.

Conditions

Frozen Sections; Indocyanine Green (ICG); Brain Tumor

Keywords

diagnostic imaging; intraoperative; confocal laser endomicroscopy

Outcome Measures

Primary Outcomes (1)

• The diagnostic accuracy of cCeLL imaging, compared with frozen section (FS), using the permanent section (PS) as the reference standard.

  cCeLL and FS diagnostic accuracy will be compared to PS, reporting sensitivity, specificity, PPV, NPV, and overall accuracy with 95% CIs. Analyses are descriptive, summarized by dataset, tumor type, and sampling site.

  Visit 1 (Surgery Day / Intervention Day) as D-Day

Secondary Outcomes (5)

• Diagnostic Performance of cCeLL vs FS Across Tumor Types and Sampling Sites

  Visit 1 (Surgery Day / Intervention Day) as D-Day

• Rate of Non-diagnostic Images with cCeLL

  Visit 1 (Surgery Day / Intervention Day) as D-Day

• Diagnostic Time Comparison (cCeLL vs FS)

  Visit 1 (Surgery Day / Intervention Day) as D-Day

• Time Required for cCeLL Imaging/Interpretation

  Visit 1 (Surgery Day / Intervention Day) as D-Day

• Detection of Positive Surgical Margins with cCeLL

  Visit 1 (Surgery Day / Intervention Day) as D-Day

Study Arms (1)

cCeLL - In vivo Imaging

EXPERIMENTAL

Participants diagnosed with brain tumors will receive an intravenous injection of Indocyanine Green (ICG) during surgery. The cCeLL - In vivo confocal laser fluorescence microscope will be used to capture real-time images of the tumor margins before tissue collection. Standard frozen section and permanent section analyses will then be performed for diagnostic comparison.

Device: cCeLL In vivo; Drug: Indocyanine Green

Interventions

cCeLL In vivo DEVICE

Dosage Form: Intravenous injection Dosage: 0.1 - 0.5 mg/kg of Indocyanine Green (ICG) Frequency: Single administration during surgery Duration: Real-time imaging performed immediately after ICG injection and used intraoperatively for tumor margin assessment

cCeLL - In vivo Imaging

Indocyanine Green DRUG

fluorescence dye for staining tissue

cCeLL - In vivo Imaging

Eligibility Criteria

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

You may qualify if:

• Male or female patients aged 18 years or older as of the screening date
• Patients suspected of having a brain tumor who are scheduled for neurosurgery and are considered candidates for tumor resection
• Patients who understand and have signed the informed consent form

You may not qualify if:

• Normal tissue specimens obtained unavoidably during tumor resection surgery in tumor patients
• Tissue samples must be adequate for both FS and PS analysis
• Minimum lesion size of 1 cm for reliable cCeLL imaging

Sponsors & Collaborators

• VPIX Medical: lead

MeSH Terms

Conditions

Brain Neoplasms

Interventions

Indocyanine Green

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Masking Details: Pathologists will perform diagnoses without access to patient medical records and will not see prior diagnostic results. They will assess tissue samples using only de-identified information, ensuring that fluorescence imaging results do not influence their evaluation. This approach eliminates bias and maintains the integrity of the study's diagnostic comparison.
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This prospective, multicenter, evaluator-blinded clinical trial evaluates the cCeLL - In vivo confocal laser fluorescence microscope for brain tumor diagnosis during surgery. Intervention Summary Study Type: Interventional (Diagnostic) Design: Single-group assignment, evaluator-blinded Intervention: 1. ICG injection during surgery 2. Fluorescence imaging of the tumor margin using cCeLL - In vivo 3. Comparison with standard frozen and permanent section analyses 4. Blinded evaluation by pathologists This study aims to enhance tumor margin assessment and improve diagnostic accuracy during brain tumor surgery.

Study Record Dates

• First Submitted: November 19, 2025
• First Posted: November 28, 2025
• Study Start: December 1, 2025
• Primary Completion (Estimated): May 30, 2026
• Study Completion (Estimated): August 30, 2026
• Last Updated: November 28, 2025

Record last verified: 2025-11