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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

NCT ID: NCT07254845

Last Updated: 2025-11-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE1

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-12-01

Study Completion Date

2026-08-30

Brief Summary

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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.

Detailed Description

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Conditions

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Frozen Sections Indocyanine Green (ICG) Brain Tumor

Keywords

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diagnostic imaging intraoperative confocal laser endomicroscopy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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.
Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

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.

Study Groups

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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.

Group Type EXPERIMENTAL

cCeLL In vivo

Intervention Type 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

Indocyanine Green

Intervention Type DRUG

fluorescence dye for staining tissue

Interventions

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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

Intervention Type DEVICE

Indocyanine Green

fluorescence dye for staining tissue

Intervention Type DRUG

Eligibility Criteria

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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

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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VPIX Medical

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Other Identifiers

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cCeLL_II_2025_Cedars

Identifier Type: -

Identifier Source: org_study_id