Brain Tumor, Frozen Sections, Indocyanine Green (ICG)
Conditions
Keywords
diagnostic imaging, intraoperative, confocal laser endomicroscopy
Brief 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.
Interventions
DEVICEcCeLL 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
DRUGIndocyanine Green
fluorescence dye for staining tissue
Sponsors
VPIX Medical
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Masking description
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.
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Male or female patients aged 18 years or older as of the screening date 2. Patients suspected of having a brain tumor who are scheduled for neurosurgery and are considered candidates for tumor resection 3. Patients who understand and have signed the informed consent form
Exclusion criteria
1. Specimens obtained from patients who have agreed to participate in this clinical trial and who meet the inclusion criteria 2. Normal tissue specimens obtained unavoidably during tumor resection surgery in tumor patients 3. Tissue samples must be adequate for both FS and PS analysis 4. Minimum lesion size of 1 cm for reliable cCeLL imaging
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The diagnostic accuracy of cCeLL imaging, compared with frozen section (FS), using the permanent section (PS) as the reference standard. | Visit 1 (Surgery Day / Intervention Day) as D-Day | cCeLL and FS diagnostic accuracy will be compared to PS, reporting sensitivity, specificity, PPV, NPV, and overall accuracy with 95% CIs. Analyses are descriptive, summarized by dataset, tumor type, and sampling site. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Diagnostic Performance of cCeLL vs FS Across Tumor Types and Sampling Sites | Visit 1 (Surgery Day / Intervention Day) as D-Day | Diagnostic indices (sensitivity, specificity, accuracy) will be calculated for each tumor type and sampling site using PS as the reference. cCeLL and FS performance will be compared side by side within subgroups descriptively, without statistical testing due to small sample sizes. |
| Rate of Non-diagnostic Images with cCeLL | Visit 1 (Surgery Day / Intervention Day) as D-Day | The number of non-diagnostic cCeLL images will be reported, with N\_ND representing non-diagnostic images and N\_Total the total images acquired. |
| Diagnostic Time Comparison (cCeLL vs FS) | Visit 1 (Surgery Day / Intervention Day) as D-Day | Acquisition and interpretation times for cCeLL and FS will be summarized, with differences described; a positive value indicates time saved using cCeLL. |
| Time Required for cCeLL Imaging/Interpretation | Visit 1 (Surgery Day / Intervention Day) as D-Day | The average and range of regions imaged per case, along with cCeLL acquisition and interpretation times, will be summarized to assess operational feasibility and real-time workflow integration during neurosurgery. |
| Detection of Positive Surgical Margins with cCeLL | Visit 1 (Surgery Day / Intervention Day) as D-Day | For post-resection scans, biopsies will be performed only if cCeLL is positive, and the Positive Margin Detection Rate will be used to assess cCeLL's ability to identify residual tumor at surgical margins |
Outcome results
None listed