Multi-center Study on CCeLL-In Vivo's Clinical Efficacy for Intraoperative Brain Tumor Diagnosis. (PRECISION)

A Prospective, Multi-Center, Assessor-Blinded Study on the Clinical Efficacy of CCeLL-In Vivo (Confocal Fluorescence Endomicroscopy) for Intraoperative Brain Tumor Diagnosis.

The primary objective of this study is to demonstrate the non-inferiority of cCeLL 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, which is then read and analyzed by trained-professional for intraoperative diagnosis. The comparison will be held by the device with 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; Frozen Sections
• Intervention / Treatment: Device: cCeLL In vivo; Drug: Indocyanine Green

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Phase 1

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• Male or female patients aged 18 years or older
• 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

The specimens used in this study must meet all of the following criteria:

• Specimens obtained from patients who have agreed to participate in this clinical trial and who meet the inclusion criteria
• Normal tissue specimens obtained unavoidably during tumor resection surgery in tumor patients

Exclusion Criteria:

• Patients undergoing multiple surgeries
• Patients with bacterial or viral infections
• Patients who develop allergic reactions to the investigational medical device
• Patients with a history of allergy to Indocyanine Green (ICG)
• Patients with iodine hypersensitivity
• Patients taking choleretic agents or rifampicin

Specimens meeting any of the following criteria will be excluded from this clinical trial:

- Specimens with unclear tumor presence or carcinoma diagnosis results based on the reference standard permanent section analysis

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
Non-Inferiority of Diagnostic Accuracy (Percentage of Correct Normal/Tumor Classifications) of cCeLL Compared to Frozen Biopsy	The diagnostic accuracy of cCeLL-In vivo will be assessed by measuring the percentage of correct normal/tumor classifications compared to the reference standard frozen biopsy. Non-inferiority will be determined using pre-specified statistical margins for sensitivity and specificity.	Visit 1 (Surgery Day / Intervention Day) as D-Day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Diagnostic Accuracy, Sensitivity, and Specificity of cCeLL Compared to Frozen Biopsy Across Tumor Types and Locations	The diagnostic performance of cCeLL-In vivo will be evaluated by calculating accuracy (percentage of correct diagnoses), sensitivity, and specificity across various tumor types and locations. These values will be compared to those obtained using frozen biopsy as the reference standard.	Visit 1 (Surgery Day / Intervention Day) as D-Day
Percentage of Non-Diagnostic Samples in cCeLL Imaging	The percentage of non-diagnostic samples (images that cannot be used for a definitive diagnosis) obtained using cCeLL-In vivo will be recorded. A lower rate of non-diagnostic samples would indicate higher image usability and reliability.	Visit 1 (Surgery Day / Intervention Day) as D-Day
Time (Minutes) Required to Obtain a Diagnosis Using cCeLL-In vivo vs. Frozen Biopsy Description:	The time required to obtain a definitive diagnosis will be measured in minutes, from the point of sample collection to the final diagnostic decision. The average diagnostic time for cCeLL-In vivo will be compared to the traditional frozen biopsy method to evaluate potential time efficiency improvements.	Visit 1 (Surgery Day / Intervention Day) as D-Day
Inter-Observer Agreement (Cohen's Kappa Score) Between Two Pathologists Using cCeLL-In vivo Images	The level of agreement between two independent pathologists interpreting cCeLL-In vivo images will be measured using Cohen's kappa coefficient (κ). The kappa score will quantify inter-observer agreement beyond chance, with values ranging from 0 (no agreement) to 1 (perfect agreement).	Visit 1 (Surgery Day / Intervention Day) as D-Day
Diagnostic Accuracy (Percentage of Correct Tumor Classifications) of AI-Based Brain Tumor Diagnosis Using cCeLL-In vivo Images	The accuracy of AI-based diagnosis will be measured as the percentage of correct tumor classifications (normal vs. tumor) compared to the reference standard diagnosis made by expert pathologists. Sensitivity, specificity, and overall accuracy will be calculated to evaluate AI performance.	Visit 1 (Surgery Day / Intervention Day) as D-Day

Collaborators and Investigators

• Sponsor: VPIX Medical

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2025
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: February 25, 2025
• First Submitted That Met QC Criteria: March 4, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 4, 2025
• Last Verified: March 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
• Other Study ID Numbers: cCeLL_II_2024; Republic of Korea (Other Identifier: VPIX Medical Inc.)

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