Multi-center Study on CCeLL-In Vivo's Clinical Efficacy for Intraoperative Brain Tumor Diagnosis.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: cCeLL In vivo, Indocyanine Green.
- Who it may be relevant to
- Registry conditions: Frozen Sections, Indocyanine Green, Brain Tumor. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Prospective, Multi-Center, Assessor-Blinded Study on the Clinical Efficacy of CCeLL-In Vivo (Confocal Fluorescence Endomicroscopy) for Intraoperative Brain Tumor Diagnosis.
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.
Interventions
- Device cCeLL 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 - Drug Indocyanine Green
fluorescence dye for staining tissue
Primary outcome measures
- Non-Inferiority of Diagnostic Accuracy (Percentage of Correct Normal/Tumor Classifications) of cCeLL Compared to Frozen Biopsy [Time frame: Visit 1 (Surgery Day / Intervention Day) as D-Day]
Secondary outcome measures (5)
- Diagnostic Accuracy, Sensitivity, and Specificity of cCeLL Compared to Frozen Biopsy Across Tumor Types and Locations [Time frame: Visit 1 (Surgery Day / Intervention Day) as D-Day]
- Percentage of Non-Diagnostic Samples in cCeLL Imaging [Time frame: Visit 1 (Surgery Day / Intervention Day) as D-Day]
- Time (Minutes) Required to Obtain a Diagnosis Using cCeLL-In vivo vs. Frozen Biopsy Description: [Time frame: Visit 1 (Surgery Day / Intervention Day) as D-Day]
- Inter-Observer Agreement (Cohen's Kappa Score) Between Two Pathologists Using cCeLL-In vivo Images [Time frame: Visit 1 (Surgery Day / Intervention Day) as D-Day]
- Diagnostic Accuracy (Percentage of Correct Tumor Classifications) of AI-Based Brain Tumor Diagnosis Using cCeLL-In vivo Images [Time frame: Visit 1 (Surgery Day / Intervention Day) as D-Day]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT06867978 · cCeLL_II_2024 · Republic of Korea