Clinical trial · Interventional
Multi-center Study on CCeLL-In Vivo's Clinical Efficacy for Intraoperative Brain Tumor Diagnosis.
A Prospective, Multi-Center, Assessor-Blinded Study on the Clinical Efficacy of CCeLL-In Vivo (Confocal Fluorescence Endomicroscopy) for Intraoperative Brain Tumor Diagnosis.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Brain Tumor | Brain Neoplasm | ALIAS | 0.90 |
| Frozen Sections | — | UNRESOLVED | — |
| Indocyanine Green | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| cCeLL In vivo | Device | — | UNRESOLVED |
| Indocyanine Green | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- cCeLL - In vivo Imaging
- description
- 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.
- interventionNames
- Device: cCeLL In vivo
- Drug: Indocyanine Green
Primary outcomes (1)
- measure
- Non-Inferiority of Diagnostic Accuracy (Percentage of Correct Normal/Tumor Classifications) of cCeLL Compared to Frozen Biopsy
- timeFrame
- Visit 1 (Surgery Day / Intervention Day) as D-Day
- description
- 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.
Secondary outcomes (5)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
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