Multi-center Study on CCeLL-In Vivo's Clinical Efficacy for Intraoperative Brain Tumor Diagnosis.
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorVPIX Medical
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Specimens obtained from patients who have agreed to participate in this clinical trial and who meet the inclusion criteria
Disqualifiers
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)
Trial design
Design model
Single group
Treatments tested in this trial
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
Treatment groups
100 Participants
are divided into 1 treatment groupGroup A: cCeLL - In vivo ImagingExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Non-Inferiority of Diagnostic Accuracy (Percentage of Correct Normal/Tumor Classifications) of cCeLL Compared to Frozen Biopsy
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.
Time frame
Visit 1 (Surgery Day / Intervention Day) as D-DaySecondary outcomes
1
Diagnostic Accuracy, Sensitivity, and Specificity of cCeLL Compared to Frozen Biopsy Across Tumor Types and Locations
The diagnostic performance of cCeLL-In vivo will be evaluated by calculating accuracy (percentage of correct diagnoses), sensitivity, and specificity across various tumor types and locations. These values will be compared to those obtained using frozen biopsy as the reference standard.
Time frame
Visit 1 (Surgery Day / Intervention Day) as D-Day2
Percentage of Non-Diagnostic Samples in cCeLL Imaging
The percentage of non-diagnostic samples (images that cannot be used for a definitive diagnosis) obtained using cCeLL-In vivo will be recorded. A lower rate of non-diagnostic samples would indicate higher image usability and reliability.
Time frame
Visit 1 (Surgery Day / Intervention Day) as D-Day3
Time (Minutes) Required to Obtain a Diagnosis Using cCeLL-In vivo vs. Frozen Biopsy Description:
The time required to obtain a definitive diagnosis will be measured in minutes, from the point of sample collection to the final diagnostic decision. The average diagnostic time for cCeLL-In vivo will be compared to the traditional frozen biopsy method to evaluate potential time efficiency improvements.
Time frame
Visit 1 (Surgery Day / Intervention Day) as D-Day4
Inter-Observer Agreement (Cohen's Kappa Score) Between Two Pathologists Using cCeLL-In vivo Images
The level of agreement between two independent pathologists interpreting cCeLL-In vivo images will be measured using Cohen's kappa coefficient (κ). The kappa score will quantify inter-observer agreement beyond chance, with values ranging from 0 (no agreement) to 1 (perfect agreement).
Time frame
Visit 1 (Surgery Day / Intervention Day) as D-DayLocations
Sponsors and contacts
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Source ClinicalTrials.gov
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