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.
Male or female patients aged 18 years or older as of the screening date
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
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
Tissue samples must be adequate for both FS and PS analysis
Minimum lesion size of 1 cm for reliable cCeLL imaging
Single group
cCeLL In vivo
DeviceDosage 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
Indocyanine Green
Drugfluorescence dye for staining tissue
The diagnostic accuracy of cCeLL imaging, compared with frozen section (FS), using the permanent section (PS) as the reference standard.
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.
Diagnostic Performance of cCeLL vs FS Across Tumor Types and Sampling Sites
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
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)
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
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.
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