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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| cCeLL - In vivo Imaging | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| cCeLL In vivo | Device | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Visit 1 (Surgery Day / Intervention Day) as D-Day |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Visit 1 (Surgery Day / Intervention Day) as D-Day |
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Inclusion Criteria:
Exclusion Criteria:
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Individual Participant Data (IPD) may not be shared due to patient privacy concerns, confidentiality agreements, regulatory restrictions, ethical considerations, and institutional policies. Additionally, data protection laws (e.g., GDPR, HIPAA) and proprietary research interests may limit data availability to ensure compliance and safeguard participant information.
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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:
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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.
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| Indocyanine Green | Drug | fluorescence dye for staining tissue |
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| 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. | Visit 1 (Surgery Day / Intervention Day) as D-Day |
| 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. | Visit 1 (Surgery Day / Intervention Day) as D-Day |
| 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. | Visit 1 (Surgery Day / Intervention Day) as D-Day |
| Detection of Positive Surgical Margins with cCeLL | 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 | Visit 1 (Surgery Day / Intervention Day) as D-Day |
| ID | Term |
|---|---|
| D001932 | Brain Neoplasms |
| ID | Term |
|---|---|
| D016543 | Central Nervous System Neoplasms |
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D007208 | Indocyanine Green |
| ID | Term |
|---|---|
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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