NCT07254845

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

• Status: Not Yet Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: VPIX Medical · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Frozen Sections
• Indocyanine Green (ICG)
• Brain Tumor

Interventions

Type	Name	Description
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

Timeline

• Start date: 2025-12-01
• Primary completion: 2026-05-30
• Completion: 2026-08-30
• First posted: 2025-11-28
• Last updated: 2025-11-28