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

Phase 1Not Yet RecruitingNCT06867978

VPIX Medical100 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

100

Conditions

Frozen Sections Indocyanine Green Brain Tumor

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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.