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

NCT06867978 | Not Yet Recruiting Phase 1

• 2 other identifiers: cCeLL_II_2024Republic of Korea
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Frozen Sections; Indocyanine Green; Brain Tumor

Keywords

Diagnostic Imaging; intraoperative; confocal laser endomicroscopy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Diagnostic Accuracy, Sensitivity, and Specificity of cCeLL Compared to Frozen Biopsy Across Tumor Types and Locations

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

• Percentage of Non-Diagnostic Samples in cCeLL Imaging

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

• Time (Minutes) Required to Obtain a Diagnosis Using cCeLL-In vivo vs. Frozen Biopsy Description:

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

• Inter-Observer Agreement (Cohen's Kappa Score) Between Two Pathologists Using cCeLL-In vivo Images

  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

  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
• 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:
• Normal tissue specimens obtained unavoidably during tumor resection surgery in tumor patients

You may not qualify if:

• 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

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: February 25, 2025
• First Posted: March 10, 2025
• Study Start: June 1, 2025
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: March 10, 2025

Record last verified: 2025-03