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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Brain Tumor; Indocyanine Green (ICG); Frozen Sections
• Intervention / Treatment: Device: cCeLL In vivo; Drug: Indocyanine Green

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

1. Specimens obtained from patients who have agreed to participate in this clinical trial and who meet the inclusion criteria
2. Normal tissue specimens obtained unavoidably during tumor resection surgery in tumor patients
3. Tissue samples must be adequate for both FS and PS analysis
4. Minimum lesion size of 1 cm for reliable cCeLL imaging

Study Plan

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: cCeLL - In vivo Imaging; 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; 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; Drug: Indocyanine Green; fluorescence dye for staining tissue

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Diagnostic Performance of cCeLL vs FS Across Tumor Types and Sampling Sites	Diagnostic indices (sensitivity, specificity, accuracy) will be calculated for each tumor type and sampling site using PS as the reference. cCeLL and FS performance will be compared side by side within subgroups descriptively, without statistical testing due to small sample sizes.	Visit 1 (Surgery Day / Intervention Day) as D-Day
Rate of Non-diagnostic Images with cCeLL	The number of non-diagnostic cCeLL images will be reported, with N_ND representing non-diagnostic images and N_Total the total images acquired.	Visit 1 (Surgery Day / Intervention Day) as D-Day
Diagnostic Time Comparison (cCeLL vs FS)	Acquisition and interpretation times for cCeLL and FS will be summarized, with differences described; a positive value indicates time saved using cCeLL.	Visit 1 (Surgery Day / Intervention Day) as D-Day
Time Required for cCeLL Imaging/Interpretation	The average and range of regions imaged per case, along with cCeLL acquisition and interpretation times, will be summarized to assess operational feasibility and real-time workflow integration during neurosurgery.	Visit 1 (Surgery Day / Intervention Day) as D-Day
Detection of Positive Surgical Margins with cCeLL	For post-resection scans, biopsies will be performed only if cCeLL is positive, and the Positive Margin Detection Rate will be used to assess cCeLL's ability to identify residual tumor at surgical margins	Visit 1 (Surgery Day / Intervention Day) as D-Day

Collaborators and Investigators

• Sponsor: VPIX Medical

Study record dates

Study Major Dates

• Study Start (Estimated): December 1, 2025
• Primary Completion (Estimated): May 30, 2026
• Study Completion (Estimated): August 30, 2026

Study Registration Dates

• First Submitted: November 19, 2025
• First Submitted That Met QC Criteria: November 19, 2025
• First Posted (Actual): November 28, 2025

Study Record Updates

• Last Update Posted (Actual): November 28, 2025
• Last Update Submitted That Met QC Criteria: November 19, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: confocal laser endomicroscopy; diagnostic imaging; intraoperative
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neoplasms by Site; Neoplasms; Nervous System Neoplasms; Central Nervous System Neoplasms; Brain Neoplasms; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indoles; Indocyanine Green
• Other Study ID Numbers: cCeLL_II_2025_Cedars

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Individual Participant Data (IPD) may not be shared due to patient privacy concerns, confidentiality agreements, regulatory restrictions, ethical considerations, and institutional policies. Additionally, data protection laws (e.g., GDPR, HIPAA) and proprietary research interests may limit data availability to ensure compliance and safeguard participant information.

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