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

Phase 1

Not yet recruiting

• Conditions: Frozen Sections; Indocyanine Green; Brain Tumor
• Interventions: Device: cCeLL In vivo; Drug: Indocyanine Green

• Registration Number: NCT06867978
• Lead Sponsor: VPIX Medical

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-02-25
• Status Verified: 2025-03
• Study First Submitted QC: 2025-03-04
• Last Update Submitted: 2025-03-04
• Study First Posted: 2025-03-10
• Last Update Posted: 2025-03-10
• Study Start: 2025-06-01
• Primary Completion: 2026-06-30
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
cCeLL - In vivo Imaging	cCeLL In vivo	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.
cCeLL - In vivo Imaging	Indocyanine Green	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.

Primary Outcome Measures

Name	Time	Method
Non-Inferiority of Diagnostic Accuracy (Percentage of Correct Normal/Tumor Classifications) of cCeLL Compared to Frozen Biopsy	Visit 1 (Surgery Day / Intervention Day) as D-Day	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.

Secondary Outcome Measures

Name	Time	Method
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	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.
Percentage of Non-Diagnostic Samples in cCeLL Imaging	Visit 1 (Surgery Day / Intervention Day) as D-Day	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.
Inter-Observer Agreement (Cohen's Kappa Score) Between Two Pathologists Using cCeLL-In vivo Images	Visit 1 (Surgery Day / Intervention Day) as D-Day	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).
Time (Minutes) Required to Obtain a Diagnosis Using cCeLL-In vivo vs. Frozen Biopsy Description:	Visit 1 (Surgery Day / Intervention Day) as D-Day	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.
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	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.